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Dermisplus Prevent Heel 8500002

by Frontier Therapeutics Inc.

Dermisplus Prevent Heel 8500002 is a Class I device made by Frontier Therapeutics Inc., listed in FDA GUDID since 31 Mar 2021 (UDI-DI 05056279304122), 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 Number05056279304122 UDI-DI Date31 Mar 2021ListedStatusListed 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  • Withdrawn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
Dermisplus Prevent Heel
Generic name
Pressure-management bandage, silicone
Model / reference
8500002
Primary DI / UDI-DI
05056279304122
FDA product code
FMP
GMDN term
Pressure-management bandage, silicone
Device class
Class I
Regulation number
880.6450
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FMP (Protector, Skin Pressure).

Other devices from Frontier Therapeutics Inc.

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Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)