Derma-Gide®

GUDID 07610221017126

Geistlich Pharma AG

Collagen wound matrix dressing

Primary Device ID	07610221017126
NIH Device Record Key	4ceffa43-6be3-428a-9fdd-03264dda7330
Commercial Distribution Status	In Commercial Distribution
Brand Name	Derma-Gide®
Version Model Number	500427
Company DUNS	480781728
Company Name	Geistlich Pharma AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter
Width	3 Centimeter
Height	4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07610221017126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182838

FDA Product Code

KGN	Wound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2025-07-09
Device Publish Date	2025-07-01

On-Brand Devices [Derma-Gide®]

07610221017140	500480
07610221017133	500474
07610221017126	500427

Trademark Results [Derma-Gide]

Mark Image Registration \| Serial	Company Trademark Application Date
DERMA-GIDE 87778417 5524973 Live/Registered	Geistlich Pharma AG 2018-01-31

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