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 nerve block tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGJ
Regulation Number 868.5140
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 6 6
2021 1 1
2022 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Contamination /Decontamination Problem 3 3
Contamination 2 2
Material Puncture/Hole 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 Busse Hospital Disposables, Inc. II Nov-29-2022
3 Busse Hospital Disposables, Inc. II May-28-2022
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
6 Medical Action Industries, Inc. 306 I May-12-2021
-
-