FDA.reportPublic FDA data

The Electrode Store

Primary DI
00816022021264
Brand
The Electrode Store
Company
IMPULSE MEDICAL TECHNOLOGIES, INC.
Model
WBT-DSAF
Catalog number
WBT-DSAF
Device description
"Detachable EEG Disc Electrodes, Leads, 48"" Wire; 1.5mm socket (Pack of 10)"
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022197000SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHYThe Electrode Store, Inc.2002-08-13GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816022021264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816022021264008160220212648160220212640816022021264

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080015502
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816022023657DPNCheck NC-0302026-01-09
00816022023664DPNCheckNC-0402026-01-09
00816022023671DPNCheckNC-040-C2026-01-09
00816022023688DPNCheckNC-DP22026-01-09
00816022023695DPNCheckDB-025-Training2026-01-09
00816022023701DPNCheckDB-0502026-01-09
00816022023718DPNCheckDB-050-C2026-01-09
00816022023633The Electrode StorePRO-EE6XPRO-EE6X2024-07-15
00816022020786The Electrode StoreSDN1248SDN12482016-09-24
00816022020793The Electrode StoreSDN1280SDN12802016-09-24
00816022020809The Electrode StoreSDN1248BSDN1248B2016-09-24
00816022021226The Electrode StoreDEN-12SAFDEN-12SAF2016-09-24
00816022021233The Electrode StorePRO-E12SAFPRO-E12SAF2016-09-24
00816022022025The Electrode StorePRO-E3PRO-E32016-09-24
00816022022032The Electrode StorePRO-E5PRO-E52016-09-24
00816022022070The Electrode StorePRO-E4PRO-E42016-09-24
00816022022087The Electrode Store62056620562016-09-24
00816022022094The Electrode Store62057620572016-09-24
00816022022100The Electrode Store0048330048332016-09-24
00816022022117The Electrode StoreOBM00046OBM000462016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08