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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device platelet and plasma separator for bone graft handling
Regulation Description Automated blood cell separator.
Definition Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Product CodeORG
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
HARVEST
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device expiration issue 2
Reaction 1
Unknown (for use when the device problem is not known) 1
Inadequate instructions for non-healthcare professional 1
No Information 1
Total Device Problems 6

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