GBR System

GUDID 08800041000005

Surgident Co.,Ltd.

Membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable Dental regeneration membrane fixation tack, non-bioabsorbable

Primary Device ID	08800041000005
NIH Device Record Key	4a017d2b-bed4-42b0-9d67-3d7031a4f3ab
Commercial Distribution Status	In Commercial Distribution
Brand Name	GBR System
Version Model Number	SDB-140-035
Company DUNS	689846448
Company Name	Surgident Co.,Ltd.
Device Count	5
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	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	08800041000005 [Primary]
GS1	08800041000265 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170697

FDA Product Code

DZL	Screw, Fixation, Intraosseous