Mazor X Navigation Camera

GUDID 07290109184845

MAZOR ROBOTICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290109184845
NIH Device Record Key0ada66aa-82b6-4bf3-a5d4-e3710d1f4f28
Commercial Distribution StatusIn Commercial Distribution
Brand NameMazor X Navigation Camera
Version Model NumberTPL0063-03
Company DUNS532681590
Company NameMAZOR ROBOTICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109184845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-26
Device Publish Date2021-05-18

On-Brand Devices [Mazor X Navigation Camera]

07290109181912TPL0063-01
07290109183602TPL0063-02
07290109184845TPL0063-03
07290115751291TPL0063-05
07290115751284TPL0063-04

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