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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suprapubic catheter accessories
Regulation Description Suprapubic catheter accessories.
Definition Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
Product CodeQGC
Regulation Number 876.5100
Device Class 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 1 1
Device Dislodged or Dislocated 1 1

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

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