FDA.reportPublic FDA data

MicroCel Geodesic Sensor Net

Primary DI
00863003000336
Brand
MicroCel Geodesic Sensor Net
Company
ELECTRICAL GEODESICS, INC.
Model
MCGSN 100 Series
Device description
EEG Electrode Array
Published
2016-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863003000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863003000336008630030003368630030003360863003000336

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-687-7962supportteam@egi.com

Regulatory Flags#

DUNS number
809845365
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863003000305 Geodesic EEG SystemGES 400 Series 2016-10-03
00863003000312Geodesic Photogrammetry SystemGPS 3.02016-10-04
00863003000329HydroCel Geodesic Sensor Net HCGSN 1302016-10-04
00863003000343GeoSourceGeoSource 2.02016-10-04

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