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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device depressor, orbital
Product CodeHNX
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5 5
Fluid Leak 5 5
Break 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 5 5

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