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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device circumcision tray
Regulation Description Obstetric-gynecologic specialized manual instrument.
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
2020 2 2
2021 6 6
2023 9 9
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 4 4
Appropriate Term/Code Not Available 4 4
Product Quality Problem 3 3
Dull, Blunt 3 3
Mechanical Problem 2 2
Material Integrity Problem 2 2
Disconnection 1 1
Physical Resistance/Sticking 1 1
Failure to Obtain Sample 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Remove 1 1
Material Fragmentation 1 1
Sharp Edges 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Hemorrhage/Bleeding 4 4
Insufficient Information 3 3
Genital Bleeding 2 2
Foreign Body In Patient 2 2
Skin Tears 2 2
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
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