Mazor X Surgical Instruments

GUDID 07290109184500

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

Primary Device ID	07290109184500
NIH Device Record Key	a572b937-530d-448d-a103-db9457efed78
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mazor X Surgical Instruments
Version Model Number	KIT0855-03
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	07290109184500 [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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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[07290109184500]

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[07290109184500]

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[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

Moist Heat or Steam Sterilization

[07290109184500]

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[07290109184500]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-22
Device Publish Date	2021-03-14

On-Brand Devices [Mazor X Surgical Instruments]

07290109183275	KIT0552-05
07290109181165	KIT0552-04
07290109181028	Mazor X Surgical Instruments
07290109180090	Mazor X Surgical Instruments
07290109184555	KIT0552-06
07290109184500	KIT0855-03
07290109181745	KIT0762-02

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