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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
2016 1 1
2017 1 1
2019 1 1
2020 2 2
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 2 2
Mechanical Problem 2 2
Difficult to Remove 1 1
Defective Device 1 1
Material Fragmentation 1 1
Defective Component 1 1
Dull, Blunt 1 1
Material Integrity Problem 1 1
Physical Resistance/Sticking 1 1
Detachment Of Device Component 1 1
Flaked 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
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Apr-05-2016
2 Centurion Medical Products Corporation II Feb-05-2020
3 Centurion Medical Products Corporation II Aug-06-2019
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