Erisma®-LP

GUDID 03700780630165

DOUBLE BREAKING LEVER

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: 03700780630165
• NIH Device Record Key: 2b53504b-97d7-4b80-bdd6-3c9bf38b9313
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma®-LP
• Version Model Number: 13722005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780630165 [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

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

[03700780630165]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [Erisma®-LP]

• 03700780638833: ROD HOLDER
• 03700780630165: DOUBLE BREAKING LEVER
• 03700780634385: POLYAXIAL REDUCTION SCREW
• 03700780618255: POLYAXIAL REDUCTION SCREW
• 03700780644056: ERISMA-LP CANNULATED SCREWDRIVER