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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
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 6
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
Hole in material 1
Unintended movement 1
Tear, rip or hole in device packaging 1
Material integrity issue 1
No Known Device Problem 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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