Arm Guide

GUDID 07290115752717

MAZOR ROBOTICS LTD

Stereotactic surgery system probe, reusable
Primary Device ID07290115752717
NIH Device Record Key842073e4-4417-40d5-844d-13a64a288215
Commercial Distribution StatusIn Commercial Distribution
Brand NameArm Guide
Version Model NumberMAS2330-06S
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
GS107290115752717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

Moist Heat or Steam Sterilization


[07290115752717]

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 [Arm Guide]

07290109182124MAS2330-03
07290115750577MAS2330-04S
07290115751727MAS2330-05S
07290115752717MAS2330-06S

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