Surgical System Sleeve, 10 Pack

GUDID 07290109184999

MAZOR ROBOTICS LTD

Patient surgical drape, single-use
Primary Device ID07290109184999
NIH Device Record Key6191d750-f620-4b36-88f7-fa2fe6e3ccd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical System Sleeve, 10 Pack
Version Model NumberKIT0953-02
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
GS107290109184999 [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 Date2021-07-02
Device Publish Date2021-06-24

On-Brand Devices [Surgical System Sleeve, 10 Pack]

07290109183251KIT0953-01
07290109184999KIT0953-02

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