Brainlab Elements - Trajectory Planning

GUDID 04056481142674

Brainlab AG

Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software
Primary Device ID04056481142674
NIH Device Record Key7d81266a-d21d-44d6-b9c1-7c0ddb57594f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainlab Elements - Trajectory Planning
Version Model Number2.6
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 Numbertrue
Manufacturing Datetrue
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
GS104056481142674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-02
Device Publish Date2023-04-24

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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