FDA.reportPublic FDA data

EverLast

Primary DI
00849593015882
Brand
EverLast
Company
LifeSync Corporation
Model
DE-MS170T15-5
Device description
REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 5 FT. (1.5 M), RIBBON, PVC WIRE
Published
2019-04-11
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
K142159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142159000DISPOSABLE PRE-GELLED SURFACE ELECTRODERochester Electro Medical, Inc.2015-06-03GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593015882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593015882008495930158828495930158820849593015882

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, reusableA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk/star with a conductive surface (e.g., tin, gold, silver, titanium, conductive plastic) and may include a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a reusable device after appropriate disinfection/sterilization.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-345-9800info@advantagemed.com

Regulatory Flags#

DUNS number
360791383
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849593019576American BiosurgicalCB-AB 1000 (S)AB 1000 (S)2021-06-03
00849593025508AMCCB-93523R2023-11-01
00849593017268AMCLWM-3500024/3A2020-02-21
00849593022934AMCCB-92324R-152019-07-19
00849593022965AMCCB-92330-152019-07-19
00849593023436AMCCB-925006-62019-09-18
00849593023474AMCCB-925007-42019-09-17
00849593007887AMCCBM-73331R2019-04-04
00849593008150AMCCBM-61596R2019-04-04
00849593023481AMCCB-925007-62019-04-03
00849593003032AMCCB-92386MX2019-04-02
00849593003216AMCCB-92578R2019-04-02
00849593004947AMCCB-92383R2019-04-02
00849593022927AMCCB-92324R2019-04-02
00849593023184AMCCB-92385R2019-04-02
00849593023191AMCCB-923862019-04-02
00849593023405AMCCB-925006-122019-04-02
00849593023627AMCCB-925852019-04-02
00849593000451AMCCB-86540R2019-04-01
00849593001144AMCLW-3500024/3A2018-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08