FDA.reportPublic FDA data

MediMax Tech

Primary DI
20817325022600
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
RSEEG-12 EEG Cups
Device description
RSEEG-12 Cups: Reusable, Silver Cups, Silver Plated Cooper Fiber + PTFE or Silicon Sheath Leadwires, EEG Cup Electrodes with a 1.2m Wire Length.
Published
2016-10-13
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
false

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
K153019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153019000Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc.2016-03-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817325022603PackageGS110In Commercial Distribution
20817325022600PackageGS15In Commercial Distribution
00817325022606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502260310817325022603
2081732502260020817325022600
00817325022606008173250226068173250226060817325022606

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-633-4629malorie.c@medimaxtech.com

Regulatory Flags#

DUNS number
927071162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00817325025003iVisionOCV-20-S12026-04-30
00817325025010iChopperIC-27G2026-04-30
00817325023764MediMax TechPSF22020-09-24
00817325023771MediMax TechASF32020-09-24
00817325023788MediMax TechASFN32020-09-24
00817325023795MediMax TechASFT032020-09-24
00817325023801MediMax TechTS32020-11-16
00817325023818MediMax TechTV32020-11-16
00817325023825MediMax TechTO3 2020-11-16
00817325026574MediMaxTech Inc.MSH22M2024-03-25
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
00817325020381MediMax TechNCS-SG15 Surface Electrodes2016-08-19
00817325020398MediMax TechMF2409 Surface Electrodes2016-08-19
00817325020350MediMax TechSG15R Surface Electrodes2016-08-19
00817325020367MediMax TechSG15G Surface Electrodes2016-08-19
00817325022729MediMax TechSG15G Surface Electrodes- 5 pc Sample Pack2017-01-18
00817325020695MediMax TechInnostim Tens 1k Unit2016-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02