Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device neurological tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJG
Regulation Number 882.4525
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 7 7
2019 3 3
2020 8 8
2021 9 9
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5 5
Material Fragmentation 4 4
Break 4 4
Detachment of Device or Device Component 3 3
Appropriate Term/Code Not Available 3 3
Material Frayed 3 3
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 1 1
Contamination 1 1
Fire 1 1
Loose or Intermittent Connection 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 5 5
Foreign Body In Patient 3 3
Insufficient Information 2 2
No Patient Involvement 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II May-06-2022
3 Avid Medical, Inc. II Mar-19-2020
4 Integra LifeSciences Corp. II Mar-22-2022
5 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
6 Medline Industries Inc II Dec-10-2021
7 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
-
-