360° Bridge KIT2313-03

GUDID 07290115752281

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

• Primary Device ID: 07290115752281
• NIH Device Record Key: 707d18e1-b9fd-4eb9-a7b2-24a2ee2345f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 360° Bridge
• Version Model Number: MAS2313-04
• Catalog Number: KIT2313-03
• Company DUNS: 532681590
• Company Name: MAZOR ROBOTICS LTD
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115752281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230064

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

[07290115752281]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-07
• Device Publish Date: 2024-12-30

On-Brand Devices [360° Bridge]

• 07290109184142: MAS2313-01
• 07290109181394: MAS2313-02
• 07290115752281: MAS2313-04