Mazor X Surgical Instruments

GUDID 07290115752229

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

• Primary Device ID: 07290115752229
• NIH Device Record Key: fff5a322-0375-4652-b242-050a4983f945
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mazor X Surgical Instruments
• Version Model Number: KIT0762-04
• 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: true
• 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	07290115752229 [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

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

Moist Heat or Steam Sterilization

[07290115752229]

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 [Mazor X Surgical Instruments]

• 07290109183275: KIT0552-05
• 07290109181165: KIT0552-04
• 07290109181028: Mazor X Surgical Instruments
• 07290109180090: Mazor X Surgical Instruments
• 07290109184555: KIT0552-06
• 07290109184500: KIT0855-03
• 07290109181745: KIT0762-02
• 07290115752229: KIT0762-04