Viewer 5.4

GUDID 04056481144654

Brainlab AG

Multidisciplinary medical image management software
Primary Device ID04056481144654
NIH Device Record Key18da3a5e-992c-435d-8c72-a71956f74cea
Commercial Distribution StatusIn Commercial Distribution
Brand NameViewer 5.4
Version Model Number5.4
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481144654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-13
Device Publish Date2024-11-05

Devices Manufactured by Brainlab AG

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
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01
04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.)2024-07-26

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