AccessGUDID - DEVICE: Brainlab Elements Guide XT, Guide 3.0 (04056481142032)

GUDID

Device Identifier (DI) Information

Brand Name: Brainlab Elements Guide XT, Guide 3.0
Version or Model: 3.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Brainlab AG

Primary DI Number: 04056481142032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314482980 *Terms of Use

Device Description: Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon.

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?
60363	Implantable electrical stimulation device management software	A software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQC	Brain Stimulation Programming Planning Software.

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: e055faa9-d2f7-4827-8c5a-622fc4f0be96
Public Version Date: November 01, 2024
Public Version Number: 4
DI Record Publish Date: April 27, 2022