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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ureteral, general & plastic surgery
Regulation Description Urological catheter and accessories.
Product CodeGBL
Regulation Number 876.5130
Device Class 2

Device Problems
Material separation 26
Device, removal of (non-implant) 5
Break 5
Tip breakage 3
Flaked 2
Material fragmentation 2
Other (for use when an appropriate device code cannot be identified) 1
Device, or device fragments remain in patient 1
No Known Device Problem 1
Total Device Problems 46

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