FDA.reportPublic FDA data

Medical Science Products

Primary DI
00864666000305
Brand
Medical Science Products
Company
SAUVRE INTERNATIONAL, LTD.
Model
4040-SD
Catalog number
4040-SD
Device description
Transcutaneous electrical stimulation electrode, Square, 40x40mm
Published
2017-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00864666000312PackageGS14In Commercial Distribution
00864666000329PackageGS124In Commercial Distribution
10864666000319PackageGS1400In Commercial Distribution
10864666000326PackageGS1120In Commercial Distribution
00864666000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864666000312008646660003128646660003120864666000312
00864666000329008646660003298646660003290864666000329
1086466600031910864666000319
1086466600032610864666000326
00864666000305008646660003058646660003050864666000305

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Width40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Regulatory Flags#

DUNS number
080557421
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851610008012Medical Science Products5050-WCSD5050-WCSD2017-10-19
00851610008036RecoverPadREPS1515REPS15152017-12-19
00851610008043RecoverPadREPS2020REPS20202017-12-19
00851610008050RecoverPadREPS2040REPS20402017-12-19
00851610008067RecoverPadREPS4560REPS45602017-12-19
00851610008180EASLIEFESLF5050ESLF50502018-01-12
00851610008197EASLIEFESLF4040ESLF40402018-01-12
00851610008203EASLIEFESLF50100ESLF501002018-01-12
00851610008210EASLIEFESLF93150ESLF931502018-01-12
00851610008289RecoverPadREPSHSREPSHS2018-01-08
00864666000336Medical Science Products5050-FSD5050-FSD2017-08-08
00864666000343Medical Science Products5090-FSD5090-FSD2017-10-19
00864666000367Medical Science Products110150-FSD110150-FSD2018-01-10
00851610008319Medical Science ProductsTS-1211TS-12112018-05-29
10851610008347Medical Science ProductsTS-1211TS-12112018-05-29
00851610008326Medical Science ProductsCOM-TENSCOM-TENS2018-05-29
10851610008026Medical Science Products5050-WCSD5050-WCSD2017-10-19
10851610008095RecoverPadREPS1515REPS15152017-12-19
10851610008125RecoverPadREPS2020REPS20202017-12-19
10851610008156RecoverPadREPS2040REPS20402017-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
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