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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, catheterization, sterile urethral, with or without catheter (kit)
Regulation Description Urological catheter and accessories.
Product CodeFCM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT - KIT 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Dec-02-2022
2 Cardinal Health 200, LLC I Feb-16-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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