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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultraviolet radiation disinfection chamber device
Definition An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.
Product CodeSCS
Regulation Number 880.6511
Device Class 2


Premarket Reviews
ManufacturerDecision
GERMITEC
  GRANTED 1
  1.  DEN230067  Chronos®

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