Stylus Marker

GUDID 07290115752120

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable Stereotactic surgery system probe, reusable

Primary Device ID	07290115752120
NIH Device Record Key	9f08b6fe-1e8e-4a06-8f64-d1bd12697f7c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stylus Marker
Version Model Number	MAS2176-07S
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	07290115752120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230064

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument