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Derma-Gide® 500474

by Geistlich Pharma AG

Derma-Gide® 500474 is a device classified as Unclassified made by Geistlich Pharma AG, cleared under FDA 510(k) K182838 on 8 Nov 2018 and listed in FDA GUDID since 1 Jul 2025 (UDI-DI 07610221017133), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K182838

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07610221017133 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK182838 Date8 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182838 decided 8 Nov 2018 Active
  • FDA GUDID UDI-DI 07610221017133 listed 1 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182838
  2. Listed FDA GUDID 07610221017133

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Derma-Gide®
Generic name
Animal-derived wound matrix dressing
Model / reference
500474
Primary DI / UDI-DI
07610221017133
FDA product code
KGN
GMDN term
Animal-derived wound matrix dressing
Device class
U
GUDID distribution status
In Commercial Distribution
Size
Width — 2 Centimeter
Height — 2 Centimeter

Related devices

Category: Animal-derived wound matrix dressing

Cleared under the same submission (K182838)

and 5 more cleared under K182838

Similar devices

Other devices filed under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)).

Other devices from Geistlich Pharma AG

See all devices from Geistlich Pharma AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)