GBR System J-TAC

GUDID 08806390822756

Jeil Medical Corporation

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	08806390822756
NIH Device Record Key	f87062a2-bff3-4f37-b4ce-876d2dab0a30
Commercial Distribution Status	In Commercial Distribution
Brand Name	GBR System J-TAC
Version Model Number	JT-CL-040
Company DUNS	688811603
Company Name	Jeil Medical Corporation
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	false
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	08806390822756 [Primary]
GS1	08806390823302 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101902

FDA Product Code

DZL	Screw, Fixation, Intraosseous