Sterile Clear Sleeve,10 pack

GUDID 07290115752212

MAZOR ROBOTICS LTD

Patient surgical drape, single-use

• Primary Device ID: 07290115752212
• NIH Device Record Key: e3d7ab0e-cea9-4a2d-9fc4-a8723651d50f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Clear Sleeve,10 pack
• Version Model Number: KIT0742-05
• 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	07290115752212 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-15
• Device Publish Date: 2022-12-18

On-Brand Devices [Sterile Clear Sleeve,10 pack]

• 07290109181141: Sterile Clear Sleeve,10 pack
• 07290109180809: KIT0742-01
• 07290109184975: KIT0742-03
• 07290115750850: KIT0742-04
• 07290115752212: KIT0742-05