DICOM VIEWER 3.2 – INSTALLER 26206-02

GUDID 04056481007102

Brainlab AG

Medical image management system
Primary Device ID04056481007102
NIH Device Record Keyd4f58879-e03c-4153-bd9f-4d1b742ddb29
Commercial Distribution StatusIn Commercial Distribution
Brand NameDICOM VIEWER 3.2 – INSTALLER
Version Model Number3.2
Catalog Number26206-02
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

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481007102 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-09

Devices Manufactured by Brainlab AG

04056481144753 - Drill Guide Array2024-06-12
04056481144760 - Drill Guide Depth Control (60 - 100 mm)2024-06-12
04056481144777 - Drill Guide Depth Control (0 - 60 mm)2024-06-12
04056481144784 - Drill Guide Tube (4.5 mm)2024-06-12
04056481144791 - Drill Guide Tube (3.2 mm)2024-06-12
04056481144807 - Drill Guide Tube (2.6 mm)2024-06-12
04056481144814 - Drill Guide Tube (2.4 mm)2024-06-12
04056481144821 - Drill Guide Tube (2.0 mm)2024-06-12

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