Geistlich Fibro-Gide®

GUDID 07610221015481

Geistlich Pharma AG

Dental soft-tissue matrix implant, animal-derived

Primary Device ID	07610221015481
NIH Device Record Key	e10bc85e-8944-4a40-8ebf-a55c4cea7cce
Commercial Distribution Status	In Commercial Distribution
Brand Name	Geistlich Fibro-Gide®
Version Model Number	500838
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	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter
Width	15 Millimeter
Height	20 Millimeter
Depth	3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07610221015481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171050

FDA Product Code

NPL	Barrier, Animal Source, Intraoral

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	2022-09-19
Device Publish Date	2022-09-09

On-Brand Devices [Geistlich Fibro-Gide®]

07610221011612	500273
07610221011605	500272
07610221015498	500839
07610221015481	500838