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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, biological sterilization process
Regulation Description Sterilization process indicator.
Product CodeFRC
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 7
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ANDERSEN STERILIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GKE-GMBH
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 16
TERRAGENE SA
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Appropriate Term/Code Not Available 531
Chemical Problem 290
Device Operates Differently Than Expected 151
Indicator 14
Environmental Particulates 7
Shelf Life Exceeded 5
Improper or Incorrect Procedure or Method 3
Adverse Event Without Identified Device or Use Problem 2
Break 2
Insufficient Information 2
Device Disinfection Or Sterilization Issue 1
False Positive Result 1
Material Separation 1
Material Fragmentation 1
Off-Label Use 1
Chemical Spillage 1
Improper Chemical Reaction 1
Total Device Problems 1014

Recalls
Manufacturer Recall Class Date Posted
1 Mesa Laboratories Bozeman Manufacturing Facility II Mar-29-2018
2 Mesa Laboratories Inc II Jan-26-2017

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