OCE

Cultured Epithelial Autograft

Product code

OCE

Device name

Cultured Epithelial Autograft

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

Flag

Life-sustaining / life-supporting

FDA classification definition

Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

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