IDYS®-C 47715002

GUDID 03700780630172

CAGE HOLDER

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780630172
• NIH Device Record Key: 96300d8a-8017-46b1-8230-ef6a7ace4eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDYS®-C
• Version Model Number: 47715002
• Catalog Number: 47715002
• 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: 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	03700780630172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130853

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

[03700780630172]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-15
• Device Publish Date: 2022-04-07

Devices Manufactured by CLARIANCE

• 03700780638109 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780638116 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780638123 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780638147 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780607969 - Erisma® Lp Spinal Fixation System: 2024-07-03 CLOSED OFFSET CONNECTOR
• 03700780607983 - Erisma® Lp Spinal Fixation System: 2024-07-03 CLOSED OFFSET CONNECTOR
• 03700780608003 - Erisma® Lp Spinal Fixation System: 2024-07-03 CLOSED OFFSET CONNECTOR
• 03700780615988 - Erisma® Deformity Spinal System: 2024-07-03 OPEN OFFSET CONNECTOR