Mazor X Guidewire Instruments Set

GUDID 07290109184449

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable
Primary Device ID07290109184449
NIH Device Record Key97a08e9c-0dda-4c22-a515-e05ec0c5c96e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMazor X Guidewire Instruments Set
Version Model NumberKIT0854-03
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS107290109184449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-22
Device Publish Date2021-03-14

On-Brand Devices [Mazor X Guidewire Instruments Set]

07290109184449KIT0854-03
07290115751437KIT0854-04

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