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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 2
  SUBSTANTIALLY EQUIVALENT - KIT 1
  1.  K811670  STERI-LOK DUAL PURPOSE PACKAGING/8400
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
  1.  K811670  STERI-LOK DUAL PURPOSE PACKAGING/8400
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 6
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 7
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 10
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 4
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 1
RILEY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGMA
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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

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

Recalls
Manufacturer Recall Class Date Posted
1 Kimberly-Clark Corporation II Mar-26-2013

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