Mazor X Guidewire Instruments Set

GUDID 07290115751437

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable

Primary Device ID	07290115751437
NIH Device Record Key	3d43f32d-25ea-438e-a3d4-214993b3fb2d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mazor X Guidewire Instruments Set
Version Model Number	KIT0854-04
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	false
Serial Number	true
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	07290115751437 [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

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

[07290115751437]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-01-10
Device Publish Date	2024-01-02

On-Brand Devices [Mazor X Guidewire Instruments Set]

07290109184449	KIT0854-03
07290115751437	KIT0854-04

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