Branch KIT2637-01

GUDID 07290109181455

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

Primary Device ID	07290109181455
NIH Device Record Key	ef49e6cb-796d-47f3-ae1b-e748779f900a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Branch
Version Model Number	MAS2637-02
Catalog Number	KIT2637-01
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	07290109181455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203005

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument