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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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).
Product CodeODS
Device Class Humanitarian Device Exemption