Idys®-LLIF 45720000

GUDID 03700780635078

TIGHTENING WRENCH

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780635078
• NIH Device Record Key: 65c63579-bf5f-4804-ae7a-cf6dd389adad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®-LLIF
• Version Model Number: 45720000
• Catalog Number: 45720000
• 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	03700780635078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202032

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

Moist Heat or Steam Sterilization

[03700780635078]

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

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• 03700780601646 - Idys® PLIF: 2025-02-03 PLIF CAGE
• 03700780601653 - Idys® PLIF: 2025-02-03 PLIF CAGE
• 03700780601660 - Idys® PLIF: 2025-02-03 PLIF CAGE
• 03700780601677 - Idys® PLIF: 2025-02-03 PLIF CAGE
• 03700780601684 - Idys® PLIF: 2025-02-03 PLIF CAGE
• 03700780601691 - Idys® PLIF: 2025-02-03 PLIF CAGE