Pelvic Case KIT2965-01

GUDID 07290109184265

MAZOR ROBOTICS LTD

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Primary Device ID	07290109184265
NIH Device Record Key	6e87e37a-4456-4101-b7ea-727fbf537653
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pelvic Case
Version Model Number	MAS2965-01
Catalog Number	KIT2965-01
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	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	07290109184265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203005

FDA Product Code

LLZ	System, Image Processing, Radiological