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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device research use only/pathology
Definition For research use only and for products imported into the US only.
Product CodeOTU
Device Class Not Classified

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 Omnyx Llc II Dec-09-2013

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