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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bandage, cast
Regulation Description Prosthetic and orthotic accessory.
Product CodeITG
Regulation Number 890.3025
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Information 1
Patient-device incompatibility 1
Material frayed 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 4

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 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Sep-18-2013

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