Idys®- C ZP 3DTi 44910006

GUDID 03700780644001

GIMBAL

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780644001
• NIH Device Record Key: 6b73b217-a57d-43c4-91ab-3667d27578ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®- C ZP 3DTi
• Version Model Number: 44910006
• Catalog Number: 44910006
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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: 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
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780644001 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

[03700780644001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14

On-Brand Devices [Idys®- C ZP 3DTi]

• 03700780644001: GIMBAL
• 03700780643837: ANGULATED PUNCH RETRACTABLE
• 03700780643820: RETRACTABLE PUNCH
• 03700780644216: SCREW
• 03700780644209: SCREW
• 03700780644193: SCREW
• 03700780644186: SCREW
• 03700780644049: SCREW
• 03700780644032: SCREW
• 03700780644025: SCREW
• 03700780644018: SCREW