Guide 2.5 Biopsy UI 55985-01

GUDID 04056481094690

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481094690
NIH Device Record Key6da782ec-47ae-4f9d-b39a-f1a495f9e422
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide 2.5 Biopsy UI
Version Model Number55985-01
Catalog Number55985-01
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exempttrue
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
GS104056481094690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481094690]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

Devices Manufactured by Brainlab AG

04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S2025-06-25
04056481145446 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L2025-06-25
04056481146320 - Alignment Software Spine2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)2025-06-23
04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) 2025-06-23
04056481145828 - Microscope Navigation 2025-06-19
04056481143985 - Mixed Reality Spine Navigation2025-06-09
04056481140809 - Curve 1.2 Dual Navigation Station2025-03-26

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