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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, incontinence, urosheath type, sterile
Regulation Description Urine collector and accessories.
Product CodeEXJ
Regulation Number 876.5250
Device Class 1


Premarket Reviews
ManufacturerDecision
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 2
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 1
Sticking 1
Hole in material 1
Structural problem 1
Total Device Problems 4

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