FDA.reportPublic FDA data

ELECTRO-GEL 16OZ. BOXED

Primary DI
00811478011913
Brand
ELECTRO-GEL 16OZ. BOXED
Company
ELECTRO-CAP INTERNATIONAL INC
Model
E9-BOXED
Catalog number
E9-BOXED
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
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111717000ELECTRO-GELElectro-Cap Intl., Inc.2012-01-05GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811478011913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811478011913008114780119138114780119130811478011913

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005272193eci@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
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
00811478010145ELECTRO-CAP W/CPZ - MEDIUME1-CPZ-ME1-CPZ-M2016-09-23

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Primary DI, Brand, Company table
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