Brainlab Elements Image Fusion

GUDID 04056481143992

Brainlab AG

Stereotactic system application software
Primary Device ID04056481143992
NIH Device Record Keydc09b243-1185-4035-8281-8b78366c9d27
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainlab Elements Image Fusion
Version Model Number4.5
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
GS104056481143992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

On-Brand Devices [Brainlab Elements Image Fusion]

040564811408164.0
040564811439924.5

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