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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device ear, nose, and throat surgical 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 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 CodeOGR
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 4 4
2021 3 3
2022 6 6
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 2 2
Device Markings/Labelling Problem 2 2
Fire 2 2
Break 2 2
Contamination /Decontamination Problem 2 2
Contamination of Device Ingredient or Reagent 1 1
Entrapment of Device 1 1
Material Fragmentation 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 3 3
Burn(s) 3 3
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Superficial (First Degree) Burn 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Sep-08-2022
4 Cardinal Health 200, LLC II Oct-10-2023
5 Centurion Medical Products Corporation II Feb-05-2020
6 Centurion Medical Products Corporation II Nov-15-2019
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
12 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
13 Medline Industries Inc II Jan-07-2021
14 ROi CPS LLC II Nov-23-2022
15 ROi CPS LLC II Jan-10-2022
16 ROi CPS LLC II Nov-18-2021
17 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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