Geistlich Fibro-Gide®

GUDID 07610221011612

Geistlich Pharma AG

Dental soft-tissue matrix implant, animal-derived

Primary Device ID	07610221011612
NIH Device Record Key	228ec950-3946-4585-86ca-5c83d821da30
Commercial Distribution Status	In Commercial Distribution
Brand Name	Geistlich Fibro-Gide®
Version Model Number	500273
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

Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter
Depth	6 Millimeter
Height	40 Millimeter
Width	20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07610221011612 [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	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-12-15

On-Brand Devices [Geistlich Fibro-Gide®]

07610221011612	500273
07610221011605	500272
07610221015498	500839
07610221015481	500838