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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wrap, sterilization
Regulation Description Sterilization wrap.
Product CodeFRG
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
  1.  K002968  MEDLINE STERILIZATION WRAP
  2.  K010825  MEDLINE STERISET STERILIZATION CONTAINER
  3.  K113353  GEMINI STERILZATION WRAP
  4.  K143147  Gemini Bonded Sterilization Wrap
  5.  K150698  Gemini Sterilization Wrap
  6.  K152458  Gemini Bonded Sterilization Wrap
  7.  K841484  STERILE O.R. BASIN KIT PRODUCT LINE
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP
  SUBSTANTIALLY EQUIVALENT 6
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
ARJO
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 8
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 16
LAC MAC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 1
MEDCO INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIKMARK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
MEDIN CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 7
  1.  K002968  MEDLINE STERILIZATION WRAP
  2.  K010825  MEDLINE STERISET STERILIZATION CONTAINER
  3.  K113353  GEMINI STERILZATION WRAP
  4.  K143147  Gemini Bonded Sterilization Wrap
  5.  K150698  Gemini Sterilization Wrap
  6.  K152458  Gemini Bonded Sterilization Wrap
  7.  K841484  STERILE O.R. BASIN KIT PRODUCT LINE
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 1
RILEY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
TSO3 INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WINNER INDUSTRIES (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 3
Failure to Adhere or Bond 2
Device Issue 2
Tear, rip or hole in device packaging 1
Hole in material 1
Material integrity issue 1
No Known Device Problem 1
Unintended movement 1
Total Device Problems 12

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 1 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Mar-23-2015
2 Advanced Sterilization Products III Dec-03-2013
3 Kimberly-Clark Corporation II Mar-26-2013

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