FDA.reportPublic FDA data

TMR-GARM-SLEE9900000

Primary DI
00858688006872
Brand
TMR-GARM-SLEE9900000
Company
Emsi
Model
SL900
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00858688006872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858688006872008586880068728586880068720858688006872

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
932471881
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859718007296Hypoallergenic Electrode 2x2 4pkBF50502025-12-16
00085971800729Hypoallergenic Electrode 2x2 4pkBF50502024-08-18
00858688006261TENS 3000EMS-DT30022016-09-24
00858688006285TENS 8000EMS-DT7202B2016-09-08
00858688006704TMR-ELTH-8500A85002016-10-14
00858688006964Electrode 45 x 45 16 PKELEC0019B2023-09-20
00858688006971Electrode 1.75 x 1.75 4 pack ELEC0008B2023-09-20
00859718007074Electrode 1.75 x 1.75 - 24 PKELEC0028B2023-09-20
00859718007081Electrode 4.0 x 7.0- DispersiveELEC407001B2023-09-20
00859718007098Electrode 1 Inch Round 4 PKSRELEC0001B2023-09-20
00859718007104"Electrode 2"" round 4pk"SRELEC0002B2023-09-20
00859718007111Electrode 3 Inch Round 4PKSRELEC0003B2023-09-20
00859718007135Electrode 2 x 4 Inch Rectangle SRELEC0005B2023-09-20
00859718007142Electrode 2 x 2 inch Square 4PKSRELC0015B2023-09-20
00859718007159Electrode 1.75 Inch SquareSRELEC0016B2023-09-20
00859718007289Flex-MI with ElectrodesFLEMC00012023-09-20
00859718007272Flex-MIFLEMC00012023-09-19
00858688006001Flex-TENSFLET00012016-09-02
00858688006018Flex-ITFLEI00012016-09-02
00858688006025Flex-MT PlusFLEMP00012016-09-02

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