ODS

Wound Covering (Composite Cultured Skin)

Product code

ODS

Device name

Wound Covering (Composite Cultured Skin)

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).