Mazor X Guidewire Instruments Case

GUDID 07290115752076

MAZOR ROBOTICS LTD

Instrument tray, reusable

• Primary Device ID: 07290115752076
• NIH Device Record Key: 53e06ac3-b012-42f7-9591-519a13f9e9d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mazor X Guidewire Instruments Case
• Version Model Number: MAS2306-04S
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	07290115752076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230064

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

[07290115752076]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-14
• Device Publish Date: 2024-11-06

Devices Manufactured by MAZOR ROBOTICS LTD

• 07290115752076 - Mazor X Guidewire Instruments Case: 2024-11-14
• 07290115752076 - Mazor X Guidewire Instruments Case: 2024-11-14
• 07290115752663 - Long Drill 4.0x80: 2024-11-14
• 07290115752670 - Long Drill 3.0x80: 2024-11-14
• 07290115752687 - Long Drill 3.0x30: 2024-11-14
• 07290115752694 - Short Drill 3.0x80: 2024-11-14
• 07290115752441 - 10.5 Arm Guide KIT: 2024-08-12
• 07290115752458 - 10.5 Arm Guide Screw Kit: 2024-08-12
• 07290115752816 - Short Drill Guide and Short Cannula: 2024-08-12