Mazor X Guidewire Instruments Set

GUDID 07290109184449

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

Primary Device ID	07290109184449
NIH Device Record Key	97a08e9c-0dda-4c22-a515-e05ec0c5c96e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mazor X Guidewire Instruments Set
Version Model Number	KIT0854-03
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	07290109184449 [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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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 Guidewire Instruments Set]

07290109184449	KIT0854-03
07290115751437	KIT0854-04

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