AccessGUDID - DEVICE: TRIUX™ neo (06430056480411)

GUDID

Device Identifier (DI) Information

Brand Name: TRIUX™ neo
Version or Model: NM27000N
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Megin Oy

Primary DI Number: 06430056480411
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 538025107 *Terms of Use

Device Description: TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electro-encephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.

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?
46495	Magnetoencephalography system, superconducting	An assembly of devices intended to be used to noninvasively detect, measure, and display bio-magnetic signals produced by electrically-active brain tissue, and to provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy [magnetoencephalography (MEG)]. It consists of a movable gantry, patient support apparatus, dewar [vessel containing liquid helium (He)], dedicated software, and a superconducting quantum interference device (SQUID) sensor array that measures the magnetic fields created by neuronal electrical currents. It is typically sited within a magnetically-shielded room (MSR).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLY	Magnetoencephalograph
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233985	000

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: 8e5d57ba-dd29-4294-b18d-a0abc791d407
Public Version Date: June 02, 2025
Public Version Number: 1
DI Record Publish Date: May 23, 2025