Geistlich Derma-Gide™ 500474
Geistlich 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 31 Jan 2019 (UDI-DI 07610221013166), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07610221013166 | Date31 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182838 | Date8 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 07610221013166
- FDA 510(k) database K182838
Across registries
- FDA 510(k) K182838 decided 8 Nov 2018 Active
- FDA GUDID UDI-DI 07610221013166 listed 31 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K182838
- Listed FDA GUDID 07610221013166
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Geistlich Derma-Gide™
- Generic name
- Animal-derived wound matrix dressing
- Model / reference
- 500474
- Primary DI / UDI-DI
- 07610221013166
- 510(k) Number
- FDA product code
- KGN
- GMDN term
- Animal-derived wound matrix dressing
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 2 CentimeterWidth — 2 Centimeter
Similar devices
Other devices filed under FDA product code KGN (Dressing, Wound, Collagen).
- KeraStat Cream by Keranetics, LLC
- COLACTIVE COLLAGEN WOUND DRESSING by Covalontechnologies, Inc.
- PriMatrix® 607-005-225 by TEI BIOSCIENCES INC.
- INTEGRA WOUND MATRIX (THIN) by Integra Lifesciences Corporation
- MicroMatrix by ACELL, INC.
- SKINTEMP by Biocore
- MicroMatrix® UBM Particulate by ACELL, INC.
- PELNAC Bilayer Wound Matrix by GUNZE LIMITED
- scaffolene CL100 Bioresorbable Collagen Matrix by Freudenberg Technology Innovation SE & Co. KG
- COLLEXA by Innocoll Pharmaceuticals