Minimally Invasive Disposable Kit

GUDID 07290115753363

MAZOR ROBOTICS LTD

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID07290115753363
NIH Device Record Keya6e62e9d-ebff-46a5-81f7-5b783f67ae7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMinimally Invasive Disposable Kit
Version Model NumberKIT0110-05
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115753363 [Primary]

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-27
Device Publish Date2023-11-19

On-Brand Devices [Minimally Invasive Disposable Kit]

07290109180953KIT0110-03
07290109184388KIT0110-04
07290115753363KIT0110-05

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