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DermaRite Medical Wound Gel- Amorphous Hydrogel 11245

by Sion Brands LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number01714196112452 UDI-DIDate1 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
DermaRite Medical Wound Gel- Amorphous Hydrogel
Generic Name
Wound hydrogel dressing, non-antimicrobial
Model / Reference
11245
Description
Amorphous Hydrogel Carbomer, Paraben & CHG Free Donates moisture to create an optimal moist wound healing enviornment
Primary DI / UDI-DI
01714196112452
FDA Product Code
NAE
GMDN Term
Wound hydrogel dressing, non-antimicrobial
Device Class
Class I
Regulation Number
878.4022
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No