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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, applicator, radionuclide, manual
Regulation Description Manual radionuclide applicator system.
Product CodeIWJ
Regulation Number 892.5650
Device Class 1


Premarket Reviews
ManufacturerDecision
BEST INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Break 3
Device inoperable 2
Device, or device fragments remain in patient 1
Failure to discharge 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 Alpha Omega Services Inc II Oct-22-2008
2 Medical Device Technologies, Inc. II Jul-13-2010
3 Worldwide Medical Technologies, LLC II Oct-12-2011

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