Geistlich Bio-Gide® Compressed

GUDID 07610221012213

Geistlich Pharma AG

Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane

Primary Device ID	07610221012213
NIH Device Record Key	3d007b90-1f02-46f8-9ffe-a97acfa5cf5c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Geistlich Bio-Gide® Compressed
Version Model Number	500374
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	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter
Width	20 Millimeter
Height	30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07610221012213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171643

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 Bio-Gide® Compressed]

07610221012213	500374
07610221012114	500363