← FDA Medical Device Classifications

Cultured Epithelial Autograft

OCE · f · Unknown

Classification

FDA Product Code
OCE
Device class
f
Regulation
Review panel
SU
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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