FDA.reportPublic FDA data

Disposable Adhesive Surface Electrodes

Primary DI
18054655007630
Brand
Disposable Adhesive Surface Electrodes
Company
SPES MEDICA SPA
Model
DENIS02025
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120494000DISPOSABLE ADHESIVE SURFACE ELECTRODESpes Medica Srl2012-06-11GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054655007630PrimaryGS10
08054655007633Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805465500763018054655007630
08054655007633080546550076338054655007633

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Regulatory Flags#

DUNS number
514029771
Device count
400
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18054655007623Disposable Adhesive Surface ElectrodesDENIS020252016-06-17
18054655008415Disposable EMG needle electrodesDSFN3804537072025-03-03
18054655023357Disposable EMG needle electrodesDSFN3804525062025-03-03
08054655008418Disposable EMG needle electrodesDSFN3804537072025-03-03
08054655023350Disposable EMG needle electrodesDSFN3804525062025-03-03
08054655036657MR Conditional Disposable EEG Cup ElectrodeDCPEX-29B2025-02-24
18054655025986Urethral Catheter ElectrodeUE0032025-02-24
18054655026006Urethral Catheter ElectrodeUE0052025-02-24
18054655030386Urethral Catheter ElectrodeUE0172025-02-24
18054655028062Tech Tape - Adhesive TapeTAPE024-252019-10-17
18054655025627Tech Dots - Adhesive and Conductive GelDOT024-252019-09-16
18054655010876Spes Medica Subdermal Needle ElectrodesMN2013D10S2020-08-11
18054655012894Spes Medica Pudendal ElectrodePUD00012020-03-11
18054655020790Connection cableSBM1AE0012024-05-13
18054655021704Connection cableSBM1AE0022024-05-13
18054655021711Connection cableSBM1AE0032024-05-13
18054655023661AC Cream - Conductive PasteACCREAM250V-32021-12-22
18054655030034Connection cableSBM1AE0042024-05-13
18054655030720IOM Stimulator ProbesSI1B0185S2526D2021-02-04
18054655031031Disposable Adhesive Surface ElectrodesTEON2F50902021-03-23

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