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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device circumcision 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 CodeOHG
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 6 6
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 2 2
Dull, Blunt 2 2
Inadequacy of Device Shape and/or Size 2 2
Defective Component 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Physical Resistance/Sticking 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Flaked 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Tears 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Foreign Body In Patient 1 1
Genital Bleeding 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Centurion Medical Products Corporation II Aug-06-2019
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
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