AccessGUDID - DEVICE: CTF MEG (B956CO0275110)

GUDID

Device Identifier (DI) Information

Brand Name: CTF MEG
Version or Model: CTF MEG 275
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CO-0275-1-1
Company Name: CTF MEG International Services Limited Partnership

Primary DI Number: B956CO0275110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203364765 *Terms of Use

Device Description: Magnetoencephalography system (MEG), 275 channel

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030737	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: 64471b17-3211-44ec-9796-21e71a0f61d6
Public Version Date: April 04, 2023
Public Version Number: 2
DI Record Publish Date: December 01, 2020