FDA.reportPublic FDA data

EverLast™

Primary DI
00849593015943
Brand
EverLast™
Company
AMC
Model
DE-MS370T15-6
Device description
REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 6 FT. (1.8 M), RIBBON, PVC WIRE
Published
2019-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593015943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593015943008495930159438495930159430849593015943

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
080242300
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849593025133GoldSelect™DE-0037602023-01-30
20849593005344LifeSyncLS-238B2022-11-21
00084959302521GoldSelect™DGE-602022-11-18
00849593005746LifeSyncLS-2282022-11-20
20849593005764LifeSyncLS-2292022-11-20
00849593005784LifeSyncLS-228D2022-11-20
20849593005801LifeSyncLS-229D2022-11-20
00849593025140GoldSelect™DE-0037602022-11-20
00849593025157GoldSelect™DE-0037102022-11-20
00849593025164GoldSelect™DE-003748-252022-11-20
00849593025171GoldSelect™DE-003760-252022-11-20
00849593025188GoldSelect™DE-003772-252022-11-20
00849593025195GoldSelect™DE-003748-VA2022-11-18
00849593025201GoldSelect™DGE-482022-11-18
00849593025225GoldSelect™DGE-722022-11-18
00849593025232GoldSelect™DGE-1202022-11-18
00849593025249GoldSelect™DE-0037482022-11-18
00849593004138AMCCB-73331R2022-10-17
00849593031998AMCLW-3090024/5A2022-10-17
00849593025041LifeSyncAB 1000 (S)CB-AB 1000-0 (S)2022-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B195XC813waveguardeemagine Medical Imaging Solutions GmbHGXY2026-03-19
03615220004355Neuronaute IceCap 2 SmallBIOSERENITY MEDICAL DEVICES GROUPGXY2026-03-17
00860008546005Nexalin ADINEXALIN TECHNOLOGYGXY2026-03-16
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00850080988121AUVONUAN HEALTHCARE LIMITEDGXY2026-03-02
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09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004024Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004031Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004314Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004628Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004635Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004680Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004697Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004703Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004710Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004727Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004734Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004741Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004758Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02