10.5 Arm Guide Screw Kit

GUDID 07290115752458

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

• Primary Device ID: 07290115752458
• NIH Device Record Key: 4359254b-49df-4cc1-8d0e-574aba753ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10.5 Arm Guide Screw Kit
• Version Model Number: KIT1488-02
• 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: 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	07290115752458 [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

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

[07290115752458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-12
• Device Publish Date: 2024-08-04

On-Brand Devices [10.5 Arm Guide Screw Kit]

• 07290115750065: KIT1488-01
• 07290115752458: KIT1488-02