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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, straight
Regulation Description Urological catheter and accessories.
Product CodeEZD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
BIG BLUE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202566  Wiygul Catheter
BONREE MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 4
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELLSPECT AB
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Jun-08-2023
2 Wellspect HealthCare (Division of DENTSPLY IH AB) II Jul-17-2020
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