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U.S. Department of Health and Human Services

Product Classification

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Device peripheral blood processing device for wound management
Regulation Description Automated blood cell separator.
Definition Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management.
Physical State May include centrifuge and sterile single-use tubes and disposables
Technical Method Uses centrifugal methods to separate whole blood into components, after which the platelet rich plasma gel is withdrawn
Target Area Blood drawn from peripheral veins, PRP gel topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePMQ
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9245
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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