AccessGUDID - DEVICE: Ultrasound Navigation (04056481144630)

GUDID

Device Identifier (DI) Information

Brand Name: Ultrasound Navigation
Version or Model: 1.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Brainlab SE

Primary DI Number: 04056481144630
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314482980 *Terms of Use

Device Description: Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigation system which consists of a computer, a display and an infrared (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries, it provides intraoperative ultrasound functionality by: - Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.). - Acquiring 3D ultrasound data sets consisting of 2D ultrasound image slices and enabling navigation and viewing with other Brainlab IGS software, as well as further processing of this data.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62783	Electromagnetic/optical surgical navigation device tracking system	A mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ddea436-66df-454d-b280-139f9bf9e0d7
Public Version Date: September 17, 2025
Public Version Number: 3
DI Record Publish Date: April 26, 2024