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U.S. Department of Health and Human Services

Product Classification

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Device bone marrow processing device for clinical use
Definition Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use
Physical State May include centrifuge, filters, tubes, syringes, needles, other disposables and anticoagulant
Technical Method Uses centifugal and/or filtration methods to separate the bone marrow into components, after which the concentrated bone marrow cells are withdrawn
Target Area Bone marrow drawn from iliac crest or other bone marrow cavity, cBMA applied clinically
Review Panel Hematology
Product CodePZU
Premarket Review Center for Biologics Evaluation & Research (CBER)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible