FDA.reportPublic FDA data

CAP STRAPS - EXTRA SMALL

Primary DI
00811478011975
Brand
CAP STRAPS - EXTRA SMALL
Company
ELECTRO-CAP INTERNATIONAL INC
Model
E13-XSM
Catalog number
E13-XSM
Published
2016-10-17
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
00811478011975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811478011975008114780119758114780119750811478011975

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
00811478010008CAP W/AG/AGCL ELECTRODESSPECIAL CAP AGCLSPECIAL CAP AGCL2016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
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