FacetLINK MI 80-2901

GUDID 00817329024927

FacetLINK MI Tray

LINKSPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00817329024927
• NIH Device Record Key: 765dffc1-a756-43e4-855c-1df3463d2d6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FacetLINK MI
• Version Model Number: 80-2901
• Catalog Number: 80-2901
• 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

Customer Support Contacts

• Phone: 1-410-772-5465
• Email: cs@linkspine.com
• Phone: 1-410-772-5465
• Email: cs@linkspine.com
• Phone: 1-410-772-5465
• Email: cs@linkspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817329024927 [Primary]

FDA Product Code

• LRP: Tray, Surgical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00817329024927]

Moist Heat or Steam Sterilization

[00817329024927]

Moist Heat or Steam Sterilization

[00817329024927]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-07-06

On-Brand Devices [FacetLINK MI]

• 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