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U.S. Department of Health and Human Services

Product Classification
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BSD
analyzer, gas, nitrogen, partial pressure, blood-phase, non-indwelling  
3
LSZ
ventilator, high frequency  
3
MNQ
stimulator, hypoglossal nerve, implanted, apnea  
3
NJK
valve, pulmonary  
3
OAZ
one-way air-leak valve  
HDE
OIR
diaphragmatic/phrenic nerve laparoscopically-implanted stimulator  
3
OOY
bronchial thermoplasty system  
3
PDR
computer-assisted personalized sedation system  
3
PNC
catheter introducer  
not classified
POI
lung tissue sealant for lung volume reduction  
not classified
PSR
implanted phrenic nerve stimulator for central sleep apnea  
3
QGZ
electrical tumor treatment fields  
3
QKS
inhaler, metered dose or dry powder, cder or cber led  
not classified
QLI
vaporizer, cder or cber led  
not classified
QOQ
non-continuous ventilator for emergency use  
not classified
QOR
continuous ventilator, minimal ventilatory support  
not classified
QOT
emergency ventilator  
not classified
QOU
emergency resuscitator  
not classified
QOW
ventilatory assistance helmet  
not classified
QPR
neurological stimulation for emergency use  
not classified
QSF
software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and ane...  
3
QTB
nitric oxide generator and delivery system  
3
SDA
electrical tumor treatment fields for non-small cell lung cancer  
3
SDL
transvenous temporary phrenic nerve stimulator  
3
LHE
controller, closed-loop blood glucose  
3
LKV
enzyme immunoassay, fetal fibronectin  
3
LMY
monitor, skin resistance/skin temperature, for insulin reactions  
3
LTC
hyaline membrane disease assay  
3
MDS
sensor, glucose, invasive  
3
MWQ
system, test, total antioxidant status  
3
NCT
instrument, glucose, noninvasive technology  
3
NQC
test, breath analysis, volatile organic compounds  
HDE
NUK
for export only - antigen, anti-cardiac, indirect fluorescent antibody test system  
not classified
NUL
for export only - antigen, anti-skeletal, indirect fluorescent antibody test system  
not classified
OTV
research use only/clinical chemistry devices  
not classified
OYC
pump, infusion, insulin, to be used with invasive glucose sensor  
3
OZO
automated insulin dosing , threshold suspend  
3
OZP
automated insulin dosing device system, single hormonal control  
3
OZQ
automated insulin dosing device system, bihormonal control  
3
PAQ
test, nr2 antibody  
not classified
PAR
test, volatile organic compounds breath analysis  
HDE
PDA
investigational use only - clinical chemistry  
not classified
PEJ
salivary estriol test  
3
PHK
test, cell mediated immune response, liver and small bowel transplant/transplantation  
not classified
PQF
sensor, glucose, invasive, non-adjunctive  
3
PZE
sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated  
3
QCD
continuous glucose monitor, implanted, adjunctive use  
3
QHJ
sensor, glucose, implanted, non-adjunctive use  
3
SCE
ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamb...  
not classified
SCF
ldt, unmet need within an integrated healthcare system  
not classified
SCG
modified version of another manufacturer’s fda-authorized test within scope described in preamble to...  
not classified
SCH
ldt, approved by nys clep  
not classified
SCI
ivd offered as ldt, not an ldt or under a targeted enforcement discretion policy described in preamb...  
not classified
SCJ
ldt, not under a targeted enforcement discretion policy described in preamble to ldt final rule  
not classified
SFI
sensor, glucose, invasive, component of automated insulin delivery system  
3
DSQ
ventricular (assist) bypass  
3
FZC
prosthesis, arterial graft, bovine carotid artery  
3
LOT
pulse-generator, program module  
3
LOZ
artificial heart  
3
LPA
system, esophageal pacing  
3
LPB
cardiac ablation percutaneous catheter  
3
LPC
device, angioplasty, laser, coronary  
3
LWO
pulse-generator, single chamber, sensor driven, implantable  
3
LWP
implantable pulse generator, pacemaker (non-crt)  
3
LWQ
heart-valve, mechanical  
3
LWR
heart-valve, non-allograft tissue  
3
LWS
implantable cardioverter defibrillator (non-crt)  
3
LWT
occluder, balloon, vena-cava  
3
LWW
pulse-generator, single chamber, single  
3
LWX
device. laser peripheral angioplasty  
3
LWZ
tissue graft of less than 6mm  
3
LXA
tissue graft of 6mm and greater  
3
MAD
catheter, percutaneous (valvuloplasty)  
3
MAE
occluder, patent ductus, arteriosus  
3
MAF
stent, coronary  
3
MCX
catheter, coronary, atherectomy  
3
MFA
device, removal, pacemaker electrode, percutaneous  
3
MGB
device, hemostasis, vascular  
3
MIE
heart-valve, allograft  
3
MIH
system, endovascular graft, aortic aneurysm treatment  
3
MIR
shunt, portosystemic, endoprosthesis  
3
MLV
transcatheter septal occluder  
3
MNO
system, laser, transmyocardial revascularization  
3
MOM
system, hemodynamic, implantable  
3
MOU
intravascular radiation delivery system  
3
MRM
defibrillator, implantable, dual-chamber  
3
MTE
system, pacing, temporary, acute, internal atrial defibrillation  
3
MUQ
glue, surgical, arteries  
3
MVK
wearable automated external defibrillator  
3
MWG
system, oxygen, aqueous  
3
MWH
pulmonic valved conduit  
HDE
NAP
cardiac support mesh wrap  
not classified
NAV
graft, bypass, coronary artery  
HDE
NGV
system, appendage closure, left atrial  
3
NIK
defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)  
3
NIM
stent, carotid  
3
NIN
stent, renal  
3
NIO
stent, iliac  
3
NIP
stent, superficial femoral artery  
3
NIQ
coronary drug-eluting stent  
3
NIU
stent, superficial femoral artery, drug-eluting  
3
NIV
coronary covered stent  
HDE
NKE
pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)  
3
NKM
mitral valve repair devices  
3
NPS
tricuspid valve repair device, percutaneously delivered  
3
NPT
aortic valve, prosthesis, percutaneously delivered  
3
NPU
prosthesis, mitral valve, percutaneously delivered  
3
NPV
pulmonary valve prosthesis percutaneously delivered  
HDE
NPW
percutaneously delivered prostheses and tricuspid valves  
3
NVN
drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes  
3
NVY
permanent defibrillator electrodes  
3
NVZ
pulse generator, permanent, implantable  
3
NWX
catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring  
3
NXW
scaffold, infrapopliteal, absorbable  
3
OAD
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter  
3
OAE
catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation  
3
OBC
occluder, internal vessel, temporary  
3
OBD
barrier, adhesion, cardiovascular  
3
OCM
surgical cardiac ablation device, for treatment of atrial fibrillation  
3
ODT
tissue adhesive, aortic aneurysmorrhaphy  
HDE
OHA
heart valve, more than minimally manipulated allograft  
Unclassified
OJE
right ventricular bypass (assist) device  
HDE
OJX
drug eluting permanent left ventricular (lv) pacemaker electrode  
3
ONU
drug-eluting peripheral transluminal angioplasty catheter  
3
OOB
drug-eluting percutaneous transluminal coronary angioplasty catheter  
3
OSR
pacemaker/icd/crt non-implanted components  
3
OZD
temporary non-roller type left heart support blood pump  
3
OZG
transcatheter septal occluder (atrial)  
3
OZH
transcatheter septal occluder (ventricular)  
3
PAP
aortic heart valve, more than minimally manipulated allograft  
HDE
PCW
implantable pulse generator, programmer and battery charger  
not classified
PCX
artificial chordae tendinae delivery system  
not classified
PFV
system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment  
3
PIZ
combination compression/decompression manual chest pump with impedance respiratory valve  
3
PJQ
agent, occluding, vascular, permanent  
3
PKK
stent delivery system  
not classified
PNF
aortic stent  
3
PNY
absorbable coronary drug-eluting stent  
3
PRC
drug-coated peripheral transluminal angioplasty catheter  
3
PRL
iliac covered stent, arterial  
3
QAN
stent, iliac vein  
3
QBI
acute coronary syndrome event detector  
3
QCT
scaffold, dissection repair  
3
QFV
implantable pulse generator  
3
QIK
organ care system (ocs) heart system  
3
QKJ
stent, central venous  
3
QLJ
patient monitor with independent remote display and operation  
not classified
QLL
left ventricular ejection fraction screening tool  
not classified
QLM
intensive care unit, respiratory failure and hemodynamic instability tool  
not classified
QLN
extracorporeal system for carbon dioxide removal for the treatment of covid-19  
not classified
QMG
shockwave intravascular lithotripsy system  
3
QNY
remote or wearable patient monitoring device for drug induced qt prolongation monitoring  
not classified
QNZ
powered communication system for emergency use  
not classified
QOA
ppg sensor wearable for hypercoagulation detection and covid-19 screening  
not classified
QOC
temporary non-roller type left or right heart support blood pump  
not classified
QOD
extracorporeal circuit and accessories for long term respiratory cariodpulmonary failure  
not classified
QSK
hybrid stent graft, thoracic aortic lesion treatment  
3
QVG
embolization agent, vascular  
3
QWC
pulmonary stent  
3
QWM
stent graft, bypass, superficial femoral artery  
3
QWN
stent graft, infrapopliteal, venous arterialization  
3
QYI
ablation catheter, renal denervation  
3
QZI
percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electr...  
3
QZK
endovascular system for treatment of thoracoabdominal and pararenal aortic lesions  
3
SEG
leadless cardiac resynchronization therapy (crt)  
3
SEQ
covered stent vascular connector, hemodialysis access circuit  
3
KJJ
cleanser, root canal  
Unclassified
LFD
saliva, artificial  
Unclassified
LMW
solution, removal, carries  
3
LPG
material, dressing, surgical, polylactic acid  
3
LQY
locator, root apex  
Unclassified
LTG
paste, injectable for vocal cord augmentation  
3
LWM
device, electrical dental anesthesia  
Unclassified
MCL
kit, test, in vitro periodontal  
3
MQC
mouthguard, prescription  
Unclassified
MVL
cord, retraction  
Unclassified
NSJ
restoration, noble metal  
not classified
NSK
dentures, partial  
not classified
NSL
dentures, full  
not classified
NSM
restoration, resin  
not classified
NSN
restoration, resin, crown and bridge  
not classified
NSO
restoration, porcelain-fused-to-metal  
not classified
NSP
restoration, porcelain  
not classified
NSQ
restoration, base metal  
not classified
NSR
prosthesis, orthodontic  
not classified
NXJ
denture, cosmetic only  
not classified
OBR
mouthguard, over-the-counter  
Unclassified
OCO
mouthguard, migraine/tension headache  
Unclassified
OLR
oral wound dressing  
Unclassified
OLS
oral wound dressing w/drug and/or biologic  
Unclassified
PKJ
crown and bridge material, resin based  
not classified
QJX
caries detection product with drug or biologic  
3
EPG
stimulator, transdermal  
3
ESI
polymer, natural-absorbable gelatin material  
3
EWD
protector, hearing (insert)  
Unclassified
EWE
protector, hearing (circumaural)  
Unclassified
LEZ
aids, speech training for the hearing impaired (ac-powered and patient-contact)  
Unclassified
LFA
aids, speech training for the hearing impaired (battery-operated or non-patient)  
Unclassified
LFB
button, nasal septal  
Unclassified
LRA
hearing aid, tactile  
Unclassified
LXV
apparatus, vestibular analysis  
Unclassified
MCM
implant, cochlear  
3
MHE
implant, auditory brainstem  
3
MJV
device, inflation, middle ear  
Unclassified
MPV
implant, hearing, active, middle ear, partially implanted  
3
MRK
system, imaging, fluorescence  
3
OAA
aid, visual, for nausea  
not classified
OAF
implant, hearing, active, middle ear, totally implanted  
3
OAQ
electronic media, hyperacusis  
not classified
OWO
drug-eluting sinus stent  
3
PGQ
cochlear implant with combined electrical stimulation and acoustic amplification  
3
QJA
tympanostomy tube delivery product with drug  
3
QOO
ventilator tubing and accessories  
not classified
QOP
respiratory humidifier for emergency use  
not classified
QOS
continuous ventilator  
not classified
QOV
critical care ventilator  
not classified
QOX
multi-patient circuit connector  
not classified
EZZ
prosthesis, vas deferens  
3
FAA
replacer, urethral  
3
FAB
replacer, ureteral  
3
FAC
valve, ureterovesicle  
3
FAG
prosthesis, urethral sphincter  
3
FAO
device, cystometric, air  
3
FBY
cooler, esophageal and gastric  
3
FBZ
cooler, prostatic  
3
LEI
implant, anti-gastroesophageal reflux  
3
LIL
monitor, penile tumescence  
Unclassified
LJE
catheter, nephrostomy  
Unclassified
LKN
separator, automated, blood cell and plasma, therapeutic  
Unclassified
LKX
device, thermal, hemorrhoids  
Unclassified
LNL
stimulator, electrical for sperm collection  
Unclassified
LNM
agent, bulking, injectable for gastro-urology use  
3
LNQ
intestinal stimulator  
HDE
LNR
system, photopheresis, extracorporeal  
3
LOA
device, testicular hypothermia  
3
LQQ
columns, immunoadsorption in extracorporeal systems  
3
LQS
spermatocele, alloplastic  
Unclassified
LRL
cushion, hemorrhoid  
Unclassified
LTI
implant, intragastric for morbid obesity  
3
LXW
column, adsorption, low density, lipoprotein  
3
MDP
separator for therapeutic purposes, membrane automated blood cell/plasma  
3
MEQ
system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy  
3
MER
stent, urethral, prostatic, permanent or semi-permanent  
3
MES
stent, urethral, bulbous, permanent or semi-permanent  
3
MIK
device, ultrasonic, thermal ablation  
3
MIP
implanted fecal incontinence device  
3
MMY
lipoprotein, low density, removal  
3
MOA
analyzer, diagnostic, fiber optic (colon)  
3
MRE
solution, sodium hyaluronate  
3
MXQ
stent, urethral, external sphincter, permanent  
3
NAZ
stimulator, bladder  
HDE
NCV
lithotripter, shockwave (for treating gallbladder stones)  
3
NZC
stent, urethral, prostatic, semi-permanent  
3
OAY
light source system, diagnostic endoscopic  
3
OCK
transurethral occlusion insert, urinary incontinence-control, female  
3
ODH
implantable bladder-evacuation electrical stimulation system  
HDE
OKN
hyperthermia system, bladder cancer treatment, with chemotherapy  
3
OVL
hemodialyzer, high cut-off  
HDE
OYF
aspiration therapy system  
3
PAT
bladder system  
HDE
PAZ
electrical stimulation bladder system  
HDE
PBN
apheresis for focal glomerulosclerosis in adult and pediatric patients  
HDE
PDI
beta 2-microglobulin apheresis column  
HDE
PFE
gastrointestinal liner system  
not classified
PHN
protective coating, mucoadhesive application, for the rectal mucosa  
Unclassified
PHO
normothermic preservation system for transplantation of initially unacceptable donor lungs  
3
PIK
metabolic neuromodulation system  
not classified
PIM
neuromodulator for obesity  
3
PMH
mechanical compression device fecal incontinence (non-manually operated)  
HDE
QBA
normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to...  
3
QLO
immunoadsorption column for emergency use  
not classified
QNB
plasma processing system for converting alpha to pre-beta high-density lipoprotein  
HDE
QPT
stimulator, tibial, electrical, implantable, for urinary incontinence  
3
QQK
normothermic machine perfusion system for the preservation of donor livers prior to transplantation  
3
QRH
catheter, balloon, urethral, drug-coated  
3
QXB
drug coated prostatic dilation catheter for benign prostatic hyperplasia  
3
SDK
transdermal test for assessment of glomerular filtration rate  
3
SDQ
alfapump system  
3
KSJ
system, identification, hepatitis b antigen  
3
MTH
tray, leukocyte typing  
not classified
MTK
kit, sample collection, hiv  
3
MTL
monitor,test,hiv-1  
3
MTN
test, syphilis, treponemal  
not classified
MTO
software, management, microplate assay  
not classified
MTP
antibody to htlv-1, elisa  
3
MTQ
software, blood virus applications  
not classified
MTR
progenitor cell enumeration  
2
MTS
vials, challenge, endotoxin  
not classified
MVW
kit, western blot, hiv-1  
not classified
MVX
antibody, monoclonal blocking, hiv-1  
not classified
MVY
monoclonal, hiv-1  
not classified
MVZ
system, test, home, hiv-1  
3
MWB
kit, test, saliva, hiv-1&2  
3
MWO
reagent, blood bank, quality control  
not classified
MYK
kit, cord blood collection  
not classified
MYP
test, platelet antibody  
2
MYS
device, ahf, automated cryoprecipitation  
not classified
MYW
irradiation, blood indicators  
not classified
MYY
separator, semi-automated, blood component  
1
MZH
test, quantitative, for hla, non-diagnostic  
not classified
MZI
test, qualitative, for hla, non-diagnostic  
Unclassified
MZK
system, separation, hematopoietic stem cell  
3
NDV
test, ecarin clotting time (ect)  
HDE
OTQ
research use only/hematology devices  
not classified
OVG
magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid...  
HDE
PBA
ecarin clotting time  
HDE
PCZ
investigational use only - immunology  
not classified
PDC
investigational use only - hematology  
not classified
PEP
molecular erythrocyte typing test  
3
PJF
illuminator system for blood products  
3
PZT
peripheral blood processing device for osteoarthritis  
not classified
PZU
bone marrow processing device for clinical use  
not classified
PZV
peripheral blood processing device for clinical use  
not classified
QBG
assay, oral direct thrombin inhibitor  
not classified
QCZ
mechanical and enzymatic autologous skin processor for cell suspension, with applicator  
3
QPW
reagents and transportation supplies, sodium citrate blood specimen collection tube  
not classified
QWY
mechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with ap...  
3
QZV
pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury  
3
SCK
ldt, non-molecular antisera for rare rbc antigens when there is no alternative ivd  
not classified
LKB
pad, alcohol, device disinfectant  
Unclassified
LKK
pump, infusion, implanted, programmable  
3
LMQ
device, peritoneal access, subcutaneous, implanted  
3
LNY
catheter, percutaneous, long term, intraspinal  
3
LPZ
container, frozen donor tissue storage  
Unclassified
LSX
controller, closed-loop, blood-pressure  
3
LWE
bone marrow collection/transfusion kit  
2
MQT
pump, drug administration, closed loop  
3
PGO
anti-stick glass syringe  
not classified
POT
lockbox (export only)  
not classified
PWC
general wellness product  
not classified
QIX
system, transdermal delivery, cder or cber led  
not classified
QIY
nasal spray, systemic delivery, cder or cber led  
not classified
QIZ
material, implantable for controlled release, cder or cber led  
not classified
QKR
face mask within the scope of the face mask and barrier face covering enforcement policy or face mas...  
not classified
QKU
non-niosh-approved disposable filtering facepiece respirators (ffrs)  
not classified
QKY
decontamination systems for n95 respirators  
not classified
QLD
protective barrier enclosure  
not classified
QLE
protective barrier enclosure with negative pressure  
not classified
QMF
mask, surgical, eua authorized  
not classified
QOZ
barrier face covering within the scope of the face mask and barrier face covering enforcement policy  
not classified
QPK
eua faceshields  
not classified
QZT
gowns and other apparel  
not classified
KTJ
system, test, alpha-fetoprotein, ria  
3
LOK
kit, test, alpha-fetoprotein for neural tube defects  
3
LTQ
calibrator for alpha-fetoprotein in mid-pregnancy maternal serum  
3
MAN
assay, interleukin  
3
MJB
antigen, cancer 549  
3
MTF
total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer  
3
MTG
test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign con...  
3
MYZ
kit, test (donors), for bloodborne pathogen  
2
MZA
test, equipment, automated bloodborne pathogen  
not classified
MZE
test, donor, cmv  
2
MZL
kit, test, quality control for endotoxin  
not classified
NAF
antigen(complexed),prostate specific,(cpsa)  
3
NAH
system, test, tumor marker, for detection of bladder cancer  
3
NYQ
chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer  
3
OAW
cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesotheliom...  
HDE
OCB
rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection  
3
OTR
research use only/immunology devices  
not classified
OYA
p2psa  
3
OYM
prostrate cancer genes nucleic acid amplification test system  
3
OYY
leukemia translocation panel multiplex test  
not classified
PIL
test for periprosthetic joint infection  
not classified
QLC
interleukin 6  
not classified
QRF
multi-analyte test system with algorithmic analysis for detection of prostate cancer  
3
QWQ
assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors  
3
PMI
fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfr...  
3
PNK
fluorescence in situ hybridization, chromosome 17p deletion (tp53)  
3
LQI
hepatitis delta serological reagents  
3
MAQ
kit, dna detection, human papillomavirus  
3
MHR
test, anti-tumor cell susceptibility  
3
MYL
assay,enzyme linked immunosorbent,parvovirus b19 igg  
3
MYM
assay,enzyme linked immunosorbent,parvovirus b19 igm  
3
MZO
assay, enzyme linked immunosorbent, hepatitis c virus  
2
NCD
test, immunity, cell mediated, mycobacterium tuberculosis  
3
NWY
test, qualitative, detection of dengue igm and igg antibodies  
not classified
OIH
yersinia spp. reagents  
Unclassified
OJN
mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test  
3
OJO
enzyme linked immunosorbent assay for the detection of lipoarabinomannan antigen of mycobacteria  
not classified
ORL
whole blood pre-treatment t-cell enrichment reagent  
3
OTT
research use only/microbiology  
not classified
OYB
kit, rna detection, human papillomavirus  
3
PCY
investigational use only - microbiology  
not classified
POA
reagents, zika virus nucleic acid  
not classified
POG
reagents, ebola zaire virus (detected in the west africa outbreak in 2014) nucleic acid  
not classified
PYS
zika virus serological reagents (emergency use)  
not classified
QHV
multiple osteoarticular pathogen antigen kit  
not classified
QIM
bartonella spp. serological reagents  
not classified
QIN
babesia spp. serological reagents  
not classified
QIO
anaplasma spp. and ehrlichia spp. serological reagents  
not classified
QIP
rickettsia spp. (spotted fever group or typhus group) serological reagents  
not classified
QIQ
orientia spp. (scrub typhus) serological reagents  
not classified
QJR
reagents, 2019-novel coronavirus nucleic acid  
not classified
QKO
reagent, coronavirus serological  
not classified
QKP
coronavirus antigen detection test system.  
not classified
QLT
covid-19 multi-analyte respiratory panel nucleic acid devices  
not classified
QLW
covid-19 test home collection kit devices  
not classified
QMN
covid-19 multi-analyte antigen device  
not classified
QSH
coronavirus marker detection  
not classified
QSS
hiv self-tests  
3
QTA
ngs whole genome sequencing for sars-cov-2 genetic analysis  
not classified
QTP
reagents, monkeypox virus nucleic acid.  
not classified
QTQ
reagents, non-variola orthopoxvirus nucleic acid.  
not classified
QTU
reagents, non-variola orthopoxvirus or monkeypox virus singleplex antigen tests  
not classified
SAD
japanese encephalitis virus immunological/serology test  
not classified
SDM
nucleic acid test used for screening of cadaveric (non-heart-beating) donors of blood or blood produ...  
Unclassified
SDN
serology test used for screening of cadaveric (non-heart-beating) donors of blood or blood products ...  
Unclassified
BWK
stimulator, electro-acupuncture  
Unclassified
KGF
adhesive, tissue for aneurysmorrhaphy  
3
KGG
tissue adhesive for use in embolization of brain arteriovenous malformations  
3
LBK
neurosurgical ultrasonic instruments  
Unclassified
LGW
stimulator, spinal-cord, totally implanted for pain relief  
3
LHY
electrode, stabilized epidural spinal  
3
LII
monitor, intracranial pressure, implanted  
3
LKW
laser, neurosurgical  
3
LLE
stimulator, spinal-cord, implanted for peripheral vascular disease  
3
LLF
laser, neurosurgical, argon  
3
LLP
laser for pain therapy  
3
LME
monitor, blood-flow, cerebral, thermal diffusion  
3
LQD
recorder, attention task performance  
Unclassified
LYI
stimulator, subcortical, implanted for epilepsy  
3
LYJ
stimulator, autonomic nerve, implanted for epilepsy  
3
MBX
stimulator, thalamic, epilepsy, implanted  
3
MFE
agent, injectable, embolic  
3
MFR
stimulator, brain, implanted, for behavior modification  
HDE
MHY
stimulator, electrical, implanted, for parkinsonian tremor  
3
MHZ
stimulator, vestibular acceleration, therapeutic  
3
MKD
stimulator, functional walking neuromuscular, non-invasive  
3
MLQ
inhibitor, peridural fibrosis (adhesion barrier)  
3
MRU
implanted subcortical electrical stimulator (motor disorders)  
HDE
MUZ
stimulator, autonomic nerve, implanted (depression)  
3
MVV
device, acupressure  
Unclassified
MXM
cap, cooling (infants)  
3
NHL
stimulator, electrical, implanted, for parkinsonian symptoms  
3
NJE
intracranial neurovascular stent  
HDE
NPE
material, embolization, neurovascular, polymerizing or precipitating  
3
NQR
sealant, dural  
3
NZK
stimulator, low electric field, tumor treatment  
3
OBA
polymerizing, neurovascular embolization material  
HDE
OLM
deep brain stimulator for obsessive compulsive disorder (ocd)  
HDE
OPR
intrasaccular flow disruption device  
3
OUT
intracranial aneurysm flow diverter  
3
OUU
polymeric neurovascular embolization  
HDE
OVC
headframe  
not classified
OZJ
inhibitor, postoperative fibrosis (adhesion barrier)  
not classified
PAX
surgical kit  
HDE
PCQ
inhibitor, postoperative fibrosis (spine adhesion barrier)  
not classified
PFN
implanted brain stimulator for epilepsy  
3
PJS
stimulator, electrical, implanted, for essential tremor  
3
PMP
dorsal root ganglion stimulator for pain relief  
3
POH
mr-guided focused ultrasound system  
3
QCA
intracranial coil-assist stent  
3
QLK
stimulator, neuromuscular, lower back muscles, totally implanted for pain relief  
3
QRB
stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy  
3
QTK
temporary percutaneous transluminal cerebral artery dilatation device  
HDE
SAZ
stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lo...  
3
SFJ
vagus nerve stimulator for rheumatoid arthritis  
3
HHY
prosthesis, suture, cerclage  
3
LHD
device, fertility diagnostic, proceptive  
Unclassified
LLQ
cap, cervical, contraceptive  
3
LLX
catheter, sampling, chorionic villus  
3
LOB
dilator, cervical, synthetic, osmotic, pregnancy termination  
3
LTA
fluid, hysteroscopy  
3
LTY
fluid, cytological collection  
3
MCI
graft, vascular, hemodialysis access, synthetic/biological composite  
3
MCN
barrier, absorbable, adhesion  
3
MCP
stimulator, fetal, acoustic  
3
MGI
aspirator, ultrasonic  
3
MKN
catheter, balloon, transcervical  
3
MMA
oximeter, fetal pulse  
3
MNB
device, thermal ablation, endometrial  
3
MPR
stent, bladder, fetal  
HDE
MWM
sensor, electro-optical (for cervical cancer)  
3
NRZ
ablation system, high intensity focused ultrasound (hifu), mr-guided  
3
OVX
water immersion labor pool  
not classified
PAS
rf/microwave hyperthermia system, cancer treatment  
HDE
PKF
d and c tray  
not classified
QLH
system, intravaginal, for controlled release of drug substance, cder or cber led  
not classified
HPX
lens, contact (polymethylmethacrylate)  
Unclassified
LOG
catheter, balloon for retinal reattachment  
3
LOH
system, identification, contact lens  
3
LOI
laser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary  
3
LQB
medical computers and software for ophthalmic use  
3
LQE
implant, corneal, refractive  
3
LXQ
cup, eye  
Unclassified
LYX
media, corneal storage  
Unclassified
LZQ
tissue adhesive for ophthalmic use  
3
LZS
excimer laser system  
3
LZU
plug, punctum  
Unclassified
MRJ
ring, endocapsular  
3
MSI
solution, cleaning / lubricating, artificial eye  
3
MTA
lens, intraocular, phakic  
3
MUR
graft, sclera, reinforcement  
3
MWD
electrosurgical, radio frequency, refractive correction  
3
NBF
prosthesis, retinal  
HDE
NCJ
telescope, implantable, miniature  
3
ODK
refractive corneal implant  
HDE
OGO
intraocular pressure lowering implant  
3
OKS
lacrimal stents and intubation sets  
Unclassified
OTL
femtosecond laser system for refractive correction  
3

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