Cranial IGS System - Ultrasound Navigation

GUDID 04056481142650

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481142650
NIH Device Record Keyf8dbce72-f522-4e7e-b354-ef94f6d09e32
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial IGS System - Ultrasound Navigation
Version Model Number1.1
Company DUNS314482980
Company NameBrainlab AG
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com
Phone+18005975911
Emailus.support@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481142650 [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 Date2021-01-28
Device Publish Date2021-01-20

Devices Manufactured by Brainlab AG

04056481145514 - Z-touch Laser Registration Pointer2025-02-21 The Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration w
04056481144906 - Spine &Trauma Navigation2024-11-22
04056481146238 - PATIENT REFERENCE ARRAY SPINE & TRAUMA2024-11-22
04056481146603 - ADAPTER SHORT FOR PATIENT REFERENCE CLAMP2024-11-22
04056481146610 - ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY2024-11-22
04056481143916 - Spine Planning2024-11-13
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01

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