Surgical System Sleeve,10 Pack

GUDID 07290115752502

MAZOR ROBOTICS LTD

Patient surgical drape, single-use

• Primary Device ID: 07290115752502
• NIH Device Record Key: 3b2a563f-71a3-4203-8ac6-69aaa63e126c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical System Sleeve,10 Pack
• Version Model Number: KIT0953-04
• 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: 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	07290115752502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251316

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: 2025-11-28
• Device Publish Date: 2025-11-20

Devices Manufactured by MAZOR ROBOTICS LTD

• 07290115752199 - Mazor X Navigation Camera: 2025-11-28
• 07290115752502 - Surgical System Sleeve,10 Pack: 2025-11-28
• 07290115752502 - Surgical System Sleeve,10 Pack: 2025-11-28
• 07290115753462 - Mazor X Scan & Plan Disposable Kit: 2025-07-21
• 07290115753479 - Mazor X Spine Disposable Kit: 2025-07-21
• 07290115753455 - Mazor X Guidewire Instruments Set: 2025-05-15
• 07290115751307 - StarDriver Kit: 2025-05-05
• 07290115751314 - 4.75 Arm Guide Screw Kit: 2025-05-05
• 07290115751321 - 4.75 Arm Guide Kit: 2025-05-05