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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp
Regulation Description Manual surgical instrument for general use.
Product CodeHXD
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 2
Material puncture 1
Use of Device Issue 1
Residue after decontamination 1
Break 1
Explanted 1
Flaked 1
Fracture 1
Material fragmentation 1
Total Device Problems 10

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