Mazor X System- Refurbished

GUDID 07290109184524

MAZOR ROBOTICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290109184524
• NIH Device Record Key: f42e4c5b-d706-4de0-83cb-8daaf8a2fb65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mazor X System- Refurbished
• Version Model Number: TPL0059-08R
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	07290109184524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203005

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-24
• Device Publish Date: 2021-03-16

On-Brand Devices [Mazor X System- Refurbished]

• 07290109184524: TPL0059-08R
• 07290109184517: TPL0059-06R