Surgeon's Screen Sterile Sleeve,10 pack

GUDID 07290115751963

MAZOR ROBOTICS LTD

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Primary Device ID07290115751963
NIH Device Record Key0a4b85d9-42de-4df2-9a44-e7ef63f4dea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgeon's Screen Sterile Sleeve,10 pack
Version Model NumberKIT0741-05
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
GS107290115751963 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-15
Device Publish Date2022-12-18