Reference Marker

GUDID 07290115752748

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable
Primary Device ID07290115752748
NIH Device Record Keye4404198-cfe4-41c3-9201-2d46a74df3dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameReference Marker
Version Model NumberMAS1295-08S
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 Kitfalse
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
GS107290115752748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


[07290115752748]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-22
Device Publish Date2024-03-14

On-Brand Devices [Reference Marker]

07290109182032MAS1295-05
07290115750560MAS1295-06S
07290115751611MAS1295-07S
07290115752748MAS1295-08S

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