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U.S. Department of Health and Human Services

Product Classification
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Device orcel-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
Submission Type HDE
Device Class 3 (De Novo Petitions Granted)
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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