5.5/6.0 Arm Guide Kit

GUDID 07290115750966

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

• Primary Device ID: 07290115750966
• NIH Device Record Key: 43df237f-f272-46f6-b17c-cc24ca4b407f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5.5/6.0 Arm Guide Kit
• Version Model Number: KIT0897-05
• 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	07290115750966 [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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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

Moist Heat or Steam Sterilization

[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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[07290115750966]

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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 Kit]

• 07290109183220: MAS2658-02
• 07290109183657: MAS2658-03
• 07290109183923: MAS2658-04
• 07290109184760: KIT0897-04
• 07290115750966: KIT0897-05