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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device skin prep tray
Regulation Description Manual surgical instrument for general use.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeOJU
Regulation Number 878.4800
Device Class 1

Device Problems
Detachment of device component 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 American Optisurgical Inc II Jun-06-2013
2 CareFusion 213, LLC III Mar-26-2013
3 Carefusion 2200 Inc II Mar-14-2012

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