Mazor X Scan & Plan Disposable Kit

GUDID 07290115752878

MAZOR ROBOTICS LTD

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Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID07290115752878
NIH Device Record Key1de967bd-9c37-41e3-b2bd-fa68d1014f69
Commercial Distribution StatusIn Commercial Distribution
Brand NameMazor X Scan & Plan Disposable Kit
Version Model NumberKIT0571-08
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 Datetrue
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
GS107290115752878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-03-31

On-Brand Devices [Mazor X Scan & Plan Disposable Kit]

07290109183244KIT0571-04
07290109181103Mazor X Scan & Plan Disposable Kit
07290109181004Mazor X Scan & Plan Disposable Kit
07290109184487KIT0571-05
07290115750874KIT0571-06
07290115752878KIT0571-08
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