Target Extender Screw

GUDID 07290115752618

MAZOR ROBOTICS LTD

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Primary Device ID	07290115752618
NIH Device Record Key	29cf007c-bc11-4d45-85d3-a9d8f4f810c7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Target Extender Screw
Version Model Number	MAS2345-06S
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	false
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	07290115752618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230064

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument