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U.S. Department of Health and Human Services

Product Classification
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Device wound covering (composite cultured skin)
Definition Wound covering. Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities).
Physical State Solid
Technical Method Cellular Wound Dressing
Target Area Extremities
Review Panel General & Plastic Surgery
Product CodeODS
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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