5.5/6.0 Arm Guide Screw Kit

GUDID 07290115750959

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

• Primary Device ID: 07290115750959
• NIH Device Record Key: 77d2db15-0b24-4d92-a394-b48b8511f33b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5.5/6.0 Arm Guide Screw Kit
• Version Model Number: KIT0896-05
• 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: 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	07290115750959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203005

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

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[07290115750959]

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[07290115750959]

Moist Heat or Steam Sterilization

[07290115750959]

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[07290115750959]

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[07290115750959]

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[07290115750959]

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[07290115750959]

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[07290115750959]

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[07290115750959]

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[07290115750959]

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[07290115750959]

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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 [5.5/6.0 Arm Guide Screw Kit]

• 07290109181820: 5.5/6.0 Arm Guide Screw
• 07290109183640: MAS2656-02
• 07290109183916: MAS2656-03
• 07290109184753: KIT0896-04
• 07290115750959: KIT0896-05