Mazor X Scan & Plan Disposable Kit

GUDID 07290115752878

MAZOR ROBOTICS LTD

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 07290115752878
• NIH Device Record Key: 1de967bd-9c37-41e3-b2bd-fa68d1014f69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mazor X Scan & Plan Disposable Kit
• Version Model Number: KIT0571-08
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07290115752878 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [Mazor X Scan & Plan Disposable Kit]

• 07290109183244: KIT0571-04
• 07290109181103: Mazor X Scan & Plan Disposable Kit
• 07290109181004: Mazor X Scan & Plan Disposable Kit
• 07290109184487: KIT0571-05
• 07290115750874: KIT0571-06
• 07290115752878: KIT0571-08