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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device indicator, physical/chemical sterilization process
Regulation Description Sterilization process indicator.
Product CodeJOJ
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 11
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANADIAN TECHNICAL TAPE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERTAPE POLYMER INC..
  SUBSTANTIALLY EQUIVALENT 1
KEM MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
U&U MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Chemical Problem 31
Device Operates Differently Than Expected 27
Shelf Life Exceeded 6
Delivered as Unsterile Product 3
Improper or Incorrect Procedure or Method 3
Contamination / decontamination Problem 3
Expiration Date Error 2
Device Expiration Issue 2
Test Strip 2
Device Handling Problem 2
Device Disinfection Or Sterilization Issue 1
No Apparent Adverse Event 1
Material Discolored 1
Appropriate Term/Code Not Available 1
Device Rinsing Issue 1
Total Device Problems 86


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