Mazor X Surgical Instruments

GUDID 07290109181745

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable
Primary Device ID07290109181745
NIH Device Record Keyd76a8ee6-e1fd-4610-b032-e98fb75fcb13
Commercial Distribution StatusIn Commercial Distribution
Brand NameMazor X Surgical Instruments
Version Model NumberKIT0762-02
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 Numbertrue
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
GS107290109181745 [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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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[07290109181745]

Moist Heat or Steam Sterilization


[07290109181745]

Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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 Surgical Instruments]

07290109183275KIT0552-05
07290109181165KIT0552-04
07290109181028Mazor X Surgical Instruments
07290109180090Mazor X Surgical Instruments
07290109184555KIT0552-06
07290109184500KIT0855-03
07290109181745KIT0762-02

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