FacetLINK MI 80-2521

GUDID 00817329024606

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	00817329024606
NIH Device Record Key	ad5a9a01-9424-4b38-9906-ce09007ddd17
Commercial Distribution Status	In Commercial Distribution
Brand Name	FacetLINK MI
Version Model Number	80-2521
Catalog Number	80-2521
Company DUNS	067584601
Company Name	LINKSPINE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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 Issuing Agency	Device ID
GS1	00817329024606 [Primary]

LXH	Orthopedic Manual Surgical Instrument

Steralize Prior To Use	true
Device Is Sterile	false

[00817329024606]

Moist Heat or Steam Sterilization

[00817329024606]

Moist Heat or Steam Sterilization

[00817329024606]

Moist Heat or Steam Sterilization

00817329025658	FacetLINK MI Set
00817329024927	FacetLINK MI Tray
00817329024606	Facet Screw Driver Outer Tube
00817329024576	Jamshidi Needle
00817329024569	Cannulated Torque Handle
00817329024552	Reamer
00817329024545	Drill Stop
00817329024538	Drill
00817329024521	Facet Screw Screwdriver
00817329024514	Trocar Stylet
00817329024507	Trocar Stylet
00817329024491	Dilator Handle
00817329024484	Dilator 3
00817329024477	Dilator 2
00817329024460	Dilator 1