Elekta Neuromag® TRIUX

GUDID 06430056480008

The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals)

Elekta Oy

Electroencephalograph

• Primary Device ID: 06430056480008
• NIH Device Record Key: 64e7da61-54f5-498e-8a4c-885240291160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elekta Neuromag® TRIUX
• Version Model Number: NM23900N
• Company DUNS: 538025107
• Company Name: Elekta Oy
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430056480008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091393

FDA Product Code

• OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Elekta Neuromag® TRIUX]

• 06430056480015: The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (a
• 06430056480008: The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (a