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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dosimeter, ionizing radiation, implanted
Definition Verify radiation dose to organs from external radiation therapy.
Product CodeNZT
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
RADIALDYNE, LLC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Dec-19-2019
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