Elements Viewer

GUDID 04056481143619

Brainlab AG

Medical image management system
Primary Device ID04056481143619
NIH Device Record Key74034a21-d6f6-4017-9fc8-3dfb560e0015
Commercial Distribution StatusIn Commercial Distribution
Brand NameElements Viewer
Version Model Number5.2
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481143619 [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 Date2021-05-18
Device Publish Date2021-05-10

Devices Manufactured by Brainlab AG

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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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