Erisma®-LP Navigated 98709001

GUDID 03700780639212

TIGHTENING KEY FOR NAV. TAP FOR FIXED GUIDEWIRE

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: 03700780639212
• NIH Device Record Key: 9ddb3b96-87a1-48a2-984e-60f286218fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma®-LP Navigated
• Version Model Number: 98709001
• Catalog Number: 98709001
• 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: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780639212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202956

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

[03700780639212]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [Erisma®-LP Navigated]

• 03700780644148: NAVIGATED TAP FOR FIXED GUIDEWIRE (Ø5,50 MM)
• 03700780644063: DEPTH GAUGE FOR NAV. TAP FOR FIXED GUIDEWIRE
• 03700780643851: NAVIGATED TAP FOR FIXED GUIDEWIRE (Ø4,50 MM)
• 03700780639212: TIGHTENING KEY FOR NAV. TAP FOR FIXED GUIDEWIRE