FDA.reportPublic FDA data

HydroCel Geodesic Sensor Net - HCGSN 130

Primary DI
00850033571035
Brand
HydroCel Geodesic Sensor Net - HCGSN 130
Company
Magstim, Inc.
Model
473xxxx
Published
2022-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131882000GEODESICEEG SYSTEM 400 SERIES (GES 400)Electrical Geodesics, Inc.2014-02-12OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033571035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033571035008500335710358500335710350850033571035

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061639577
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033571004Geodesic EEG System - GES 400 Series140xxxx2022-01-25
00850033571011MicroCel Geodesic Sensor Net - MCGSN 100 Series479xxxx2022-01-25
00850033571028GeoSource 2.0 Source Estimation Software61500362022-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
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08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
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08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
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18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
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18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyGWQ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWQ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWQ2023-04-19
00195278524089NAGE Healthcare Finland OyGWQ2023-04-19
09342451002112SiestaCompumedics Usa, Inc.GWQ2020-12-16
09342451001788SiestaCompumedics Usa, Inc.GWQ2020-12-15
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWQ2020-05-25