FDA.reportPublic FDA data

Neurovirtual

Primary DI
00850008393006
Brand
Neurovirtual
Company
NEUROVIRTUAL USA, INC.
Model
"Maxxi Gold Electrode 96"""
Catalog number
PV1010-23CI
Device description
"Gold cup electrodes 96"" length, (5 electrodes/pack)"
Published
2019-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163547000MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96Neurovirtual USA, Inc.2017-04-11GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008393006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008393006008500083930068500083930060850008393006

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature40 Degrees Celsius104 Degrees Celsius
Storage Environment Humidity-4 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791140622
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008393358Neurovirtual"Maxxi Gold AgCl Electrode 60"" Reusable"SI21372022-02-01
00850008393365Neurovirtual"Maxxi Gold AgCl Electrode 96"""SI21382022-02-01
00850008393303Neurovirtual"Maxxi Gold AgCl Electrode 60"""SI20362020-08-10
00850008393310Neurovirtual"Maxxi Gold AgCl Electrode 96"""SI20372020-08-10
00867975000295Neurovirtual"Maxxi Gold Electrode 60"""PV1010-13CI2019-11-26
00850008393013Neurovirtual"Maxxi Gold Snap Electrode 96"""SI18782019-11-26
00850008393020Neurovirtual"Maxxi Gold Snap Electrode 60"""SI18732019-11-26
00850008393037Neurovirtual"Maxxi Gold Snap Electrode 48"""SI18722019-11-26
00850008393044Neurovirtual"Maxxi Gold Electrode 48"""PV1010-33CI2019-11-26
00850008393228NeurovirtualBWMini PSGPV23112019-11-26
00850008393235NeurovirtualBWMini EEGPV23102019-11-26
00850008393242NeurovirtualBWMini HSTPV23122019-11-26
00850008393259NeurovirtualBWMini HST CompassSI18422019-11-26
00850008393372NeurovirtualMaxxi Cannula 2ft Adult NasalSI11952023-03-03
00850008393389NeurovirtualMaxxi Cannula 7ft Adult NasalSI10582023-03-03
00850008393396NeurovirtualMaxxi Cannula 7ft Adult NasalSI10572023-03-03
00850008393174NeurovirtualBWIII BasicsPV20102019-11-26
00850008393181NeurovirtualBWIII EEGPV20062019-11-26
00850008393198NeurovirtualBWIII EEG PlusPV20072019-11-26
00850008393211NeurovirtualBWIII PSG PlusPV20092019-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
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