FDA.reportPublic FDA data

CAP W/AG/AGCL ELECTRODES

Primary DI
00811478010008
Brand
CAP W/AG/AGCL ELECTRODES
Company
ELECTRO-CAP INTERNATIONAL INC
Model
SPECIAL CAP AGCL
Catalog number
SPECIAL CAP AGCL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112319000ELECTRO-CAP SYSTEMElectro-Cap Intl., Inc.2012-01-27GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811478010008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811478010008008114780100088114780100080811478010008

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

Contacts#

Phone, Email table
PhoneEmail
800 527-2193eci@electro-cap.com

Regulatory Flags#

DUNS number
186765806
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811478010213NEEDLE/SYRINGE KIT - LARGEE41E412020-12-08
00811478011883ELECTRO-GEL 16ozE9E92016-09-23
00811478011890ELECTRO-GEL 32ozE10E102016-09-23
00811478011906ELECTRO-GEL 128OZE11E112016-09-23
00811478011913ELECTRO-GEL 16OZ. BOXEDE9-BOXEDE9-BOXED2016-09-23
00811478011920ELECTRO-GEL 32 OZ. BOXEDE10-BOXEDE10-BOXED2016-09-23
00811478010015SPECIAL CAPSPECIAL CAPSPECIAL CAP2016-09-23
00811478010022STD SURGICAL CAP-LARGE/MEDIUMCS2000-L/MCS2000-L/M2016-09-23
00811478010039STD SURGICAL CAP-MEDIUMCS2000-MCS2000-M2016-09-23
00811478010046STD SURGICAL CAP-MED/SMALLCS2000-M/SMCS2000-M/SM2016-09-23
00811478010053STD SURGICAL CAP-LARGECS2000-LCS2000-L2016-09-23
00811478010060STD SURGICAL CAP-EX SMALLCS2000-XSMCS2000-XSM2016-09-23
00811478010077EVOKED POTENTIAL CAP - LARGEEP1-LEP1-L2016-09-23
00811478010084SPECIAL CAP W/21 ELECTRODESSPECIAL CAP 1XSPECIAL CAP 1X2016-09-23
00811478010091CADWELL EASY2 SYSTEM 3EASY2-SYS3EASY2-SYS32016-09-23
00811478010107CADWELL EASY2 SYSTEM 2EASY2-SYS2EASY2-SYS22016-09-23
00811478010114CADWELL EASY2 SYSTEM 1EASY2-SYS1EASY2-SYS12016-09-23
00811478010121ELECTRO-CAP W/CPZ EX SMALLE1-CPZ-XSME1-CPZ-XSM2016-09-23
00811478010138ELECTRO-CAP W/CPZ - SMALLE1-CPZ-SME1-CPZ-SM2016-09-23
00811478010145ELECTRO-CAP W/CPZ - MEDIUME1-CPZ-ME1-CPZ-M2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02