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Scar Fx 10648

by Scar Heal

Scar Fx 10648 is a Class I device made by Scar Heal, listed in FDA GUDID since 31 Jul 2020 (UDI-DI 00642790106489), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00642790106489 UDI-DI Date31 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Scar Fx
Generic name
Scar-management dressing, reusable
Model / Ref / Catalog
10648
Primary DI / UDI-DI
00642790106489
FDA product code
MDA
GMDN term
Scar-management dressing, reusable
Device class
Class I
Regulation number
878.4025
GUDID distribution status
In Commercial Distribution
Size
Height — 6 Inch
Width — 48 Inch

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Properties

  • Premarket exempt
Other properties (14, all answered No)