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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device osteotome, manual
Regulation Description Manual surgical instrument for general use.
Product CodeGFI
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 7
Difficult to remove 7
Material separation 4
Use of Device Issue 4
Bent 2
Device alarm system issue 1
Not audible alarm 1
Material twisted 1
No code available 1
Total Device Problems 28

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