Brainlab Elements Guide XT, Guide 3.0

GUDID 04056481142032

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.

Brainlab AG

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• Primary Device ID: 04056481142032
• NIH Device Record Key: e055faa9-d2f7-4827-8c5a-622fc4f0be96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brainlab Elements Guide XT, Guide 3.0
• Version Model Number: 3.0
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481142032 [Primary]

FDA Product Code

• QQC: Brain Stimulation Programming Planning Software.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-05
• Device Publish Date: 2022-04-27

Devices Manufactured by Brainlab AG

• 04056481146221 - Quentry.com (Quentry Web) Quentry Gateway Quentry Desktop: 2024-04-15
• 04056481141660 - DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE: 2024-01-04
• 04056481144845 - Automatic Registration iMRI: 2023-11-28 Automatic Registration iMRI provides an automatic image registration for cranial indications.
• 04056481145606 - HEX SCREWDRIVER T-HANDLE (2.5 MM): 2023-10-27
• 04056481145217 - DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS): 2023-10-25
• 04056481145392 - DRAPELINK REF ADAPTER AUTO-REG IMRI: 2023-10-24
• 04056481145101 - Automatic Registration: 2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA
• 04056481143138 - Drill Bit Cranial 2.4/4.0: 2023-09-26