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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sound, urethral, metal or plastic
Product CodeFBX
Regulation Number 876.5520
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Corroded 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10

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