Erisma-LP MIS

GUDID 03700780634576

Long Handle for Kobe Persuader

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

• Primary Device ID: 03700780634576
• NIH Device Record Key: acf16941-0b40-4099-8b86-7b0ff1025f07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma-LP MIS
• Version Model Number: 15780003
• 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: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780634576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162367

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

[03700780634576]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-23
• Device Publish Date: 2022-03-15

On-Brand Devices [Erisma-LP MIS]

• 03700780634576: Long Handle for Kobe Persuader
• 03700780634569: Handle for Kober Persuader for Set Screw