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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, aspiration and injection, reusable
Regulation Description Manual surgical instrument for general use.
Product CodeGDM
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CIVCO
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 4
Material integrity issue 3
Tip breakage 1
Total Device Problems 8

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 1 1 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medical Device Technologies, Inc. II Jul-13-2010
2 Remington Medical Inc. II May-26-2009
3 Teleflex Medical II Mar-16-2016

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