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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, reproductive
Regulation Description Reproductive media and supplements.
Product CodeMQL
Regulation Number 884.6180
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 9
FERTI PRO N.V.
  SUBSTANTIALLY EQUIVALENT 2
GENX INTL., INC.
  SUBSTANTIALLY EQUIVALENT 5
HALOZYME THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 33
MEDICULT
  SUBSTANTIALLY EQUIVALENT 26
NONE
  SUBSTANTIALLY EQUIVALENT 15
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 24
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 1
Total Device Problems 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 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cook, Inc. II Mar-28-2012

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