Mazor X Spine Disposable Kit

GUDID 07290115750881

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 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 ID07290115750881
NIH Device Record Key7d2f97b4-b3c8-45b8-a1d3-d08bff18c9d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMazor X Spine Disposable Kit
Version Model NumberKIT0574-08
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 Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115750881 [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 Date2021-08-26
Device Publish Date2021-08-18

On-Brand Devices [Mazor X Spine Disposable Kit]

07290109183268KIT0574-06
07290109181110Mazor X Spine Disposable Kit
07290109181011Mazor X Spine Disposable Kit
07290109184494KIT0574-07
07290115750881KIT0574-08
07290115752786KIT0574-10
07290115753141KIT0574-11
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