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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilization wrap containers, trays, cassettes & other accessories
Regulation Description Sterilization wrap.
Product CodeKCT
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
ADROIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 4
BAHADIR USA CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 6
CONTAINMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 3
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MILTEX
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
SKLAR
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
T.A.G. MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 5
Other (for use when an appropriate device code cannot be identified) 4
Use of Device Issue 3
Melted 1
Defective item 1
Device disinfection or sterilization issue 1
Material integrity issue 1
No code available 1
Total Device Problems 17

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 3 0 0 2 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Feb-22-2011
2 Innovative Sterlization Technologies LLC II Oct-22-2015
3 Integra York PA, Inc II Sep-11-2014
4 PMBS, LLC II Mar-25-2016
5 Smith & Nephew, Inc. Endoscopy Division II Jun-24-2011
6 Stryker Endoscopy II Jun-22-2011
7 Symmetry Medical/SSI II Jan-27-2014

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