Erisma-LP

GUDID 03700780630110

Handle for Kobe Persuader

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780630110
• NIH Device Record Key: c2df2cdd-d62b-4402-bcb4-360dfa2d515c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma-LP
• Version Model Number: 15780001
• 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
• 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
• Phone: +17738687041
• Email: s.chambat@clariance-spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780630110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162367

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument
• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

Moist Heat or Steam Sterilization

[03700780630110]

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

Devices Manufactured by CLARIANCE

• 03700780614424 - Idys®-LLIF 3DTi: 2024-12-26 SHORT CAGE-HOLDER
• 03700780652440 - Spinal instrument: 2024-12-26 LIF T HANDLE (1/4")
• 03700780605026 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605033 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605040 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605057 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605064 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605071 - Erisma™-LP: 2024-12-19 Monoaxial screw