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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ostomy care kit
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodePQE
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II Feb-05-2018
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