Geistlich Bio-Gide® Perio

GUDID 07610221010394

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	07610221010394
NIH Device Record Key	4be07d00-2532-42a7-9667-dbf026e87378
Commercial Distribution Status	In Commercial Distribution
Brand Name	Geistlich Bio-Gide® Perio
Version Model Number	20148
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

Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter
Height	22 Millimeter
Width	16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07610221010394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112575

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	2018-08-08
Device Publish Date	2015-09-01

Devices Manufactured by Geistlich Pharma AG

07610221015481 - Geistlich Fibro-Gide®	2022-09-19
07610221015498 - Geistlich Fibro-Gide®	2022-09-19
07610221071906 - Wound Matrix PLUS	2022-09-19
07610221071913 - Wound Matrix PLUS	2022-09-19
07610221014200 - Geistlich Nexo-Gide®	2021-09-09
07610221014217 - Geistlich Nexo-Gide®	2021-09-09
07610221014224 - Geistlich Nexo-Gide®	2021-09-09
07610221015320 - Geistlich Bio-Oss®	2021-06-23