visor2

GUDID B195ES600US0

visor2 component

eemagine Medical Imaging Solutions GmbH

Stereotactic neuronavigation/planning system
Primary Device IDB195ES600US0
NIH Device Record Keya83e084e-d3c5-4ad7-ac18-e5a4452154d1
Commercial Distribution StatusIn Commercial Distribution
Brand Namevisor2
Version Model NumberES-600.US
Company DUNS313152485
Company Nameeemagine Medical Imaging Solutions GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com
Phone+493029048404
Emailsupport@eemagine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB195ES600US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-22
Device Publish Date2022-04-14

Devices Manufactured by eemagine Medical Imaging Solutions GmbH

B195CS315 - waveguard2023-10-10 eeg cap
B195NT1040 - tracking tools2022-09-29 visor2 component
B195NT1041 - tracking tools2022-09-29 visor2 component
B195NT106 - tracking tools2022-09-29 visor2 component
B195NT109 - tracking tools2022-09-29 visor2 component
B195NT112 - tracking tools2022-09-29 visor2 component
B195NT117 - tracking tools2022-09-29 visor2 component
B195NT118 - tracking tools2022-09-29 visor2 component

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