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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device male external catheterization kit (excludes hiv testing)
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 CodePPC
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incomplete or Missing Packaging 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

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