FDA.reportPublic FDA data

NeuroPlus™

Primary DI
60813150020864
Brand
NeuroPlus™
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
A10040-60
Catalog number
A10040-60
Device description
Disposable Medical Electrodes 60 per pouch, 10 pouch per case 600 per case
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
60813150020864PrimaryGS10
50813150020867Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6081315002086460813150020864
5081315002086750813150020867

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.669.6905customerservice@vermed.com

Regulatory Flags#

DUNS number
002111896
Device count
100
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30009336010593Nissha Medical TechnologiesO-4227-604010453C2026-02-26
30009336010609Nissha Medical TechnologiesO-5235-604010425C2026-02-26
03700506307067BardBardIPC730412019-08-30
03700506307081BiosenseCARTO3IPC730802019-08-30
03700506307098Physio ControlLifepackIPC735112019-08-30
03700506307104St Jude MedicalSt Jude MedicalIPC737452019-08-30
00009336010332SilverRest Resting ECG TAB ElectrodeA100246500045V2024-11-14
00009336002559VermedLWG-6090029/3ALWG-6090029/3A2016-09-24
00009336002573VermedLWG-3090029/3ALWG-3090029/3A2016-09-24
00009336002597VermedLWG-3090029/5ALWG-3090029/5A2017-05-02
00009336002603VermedLWG-2090029GR LWG-2090029GR 2016-09-24
00009336002610VermedLWG-2090029RDLWG-2090029RD2016-09-24
00009336002627VermedLWG-2090029WH LWG-2090029WH 2016-09-24
00009336002665VermedLWG-2090029/3A LWG-2090029/3A 2016-09-24
00009336002672VermedLWG-2090029/5ALWG-2090029/5A2016-09-24
00009336002689VermedLWG-2090029BK LWG-2090029BK 2016-09-24
00009336002696VermedLWG-2090029BR LWG-2090029BR 2016-09-24
00009336002795VermedLWG-3300051/5ALWG-3300051/5A2016-09-24
00009336002863VermedLWG-3300029/5ALWG-3300029/5A2016-09-24
00009336002870VermedLWG-3300029/5AT LWG-3300029/5AT 2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594795Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-20
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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
09342451004772Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-03
00850080988121AUVONUAN HEALTHCARE LIMITEDGXY2026-03-02
09342451003904Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451003980Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004611Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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09342451004635Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004642Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004659Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
09342451004673Compumedics Quik-CapCOMPUMEDICS LIMITEDGXY2026-03-02
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