Leforte System Bone Screw / GBR System Bone Screw

GUDID 08809265155126

Jeil Medical Corporation

Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

Primary Device ID	08809265155126
NIH Device Record Key	4c6159c8-4566-4c17-bd26-0ded5771b10f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Leforte System Bone Screw / GBR System Bone Screw
Version Model Number	16-AT-008
Company DUNS	688811603
Company Name	Jeil Medical Corporation
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	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	08809265155126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K023365

FDA Product Code

DZL	Screw, Fixation, Intraosseous