Idys®-ALIF 3DTI 46761000

GUDID 03700780635061

Graft impactor

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780635061
• NIH Device Record Key: d32655c8-9f6d-4075-bf19-f372988a6d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®-ALIF 3DTI
• Version Model Number: 46761000
• Catalog Number: 46761000
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780635061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200919

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

[03700780635061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

On-Brand Devices [ Idys®-ALIF 3DTI]

• 03700780635061: Graft impactor
• 03700780635054: Graft impactor