Brainlab Elements Image Fusion Angio

GUDID 04056481138530

Brainlab AG

Radiology picture archiving and communication system application software
Primary Device ID04056481138530
NIH Device Record Keybc8a1c9c-58bb-446e-a72a-463661913787
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainlab Elements Image Fusion Angio
Version Model Number1.0
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481138530 [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 Date2019-05-13
Device Publish Date2019-05-03

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