Surgical System Sleeve, 10 Pack

GUDID 07290109184999

MAZOR ROBOTICS LTD

Patient surgical drape, single-use

• Primary Device ID: 07290109184999
• NIH Device Record Key: 6191d750-f620-4b36-88f7-fa2fe6e3ccd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical System Sleeve, 10 Pack
• Version Model Number: KIT0953-02
• 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: false
• 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	07290109184999 [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: 2021-07-02
• Device Publish Date: 2021-06-24

On-Brand Devices [Surgical System Sleeve, 10 Pack]

• 07290109183251: KIT0953-01
• 07290109184999: KIT0953-02