FDA.reportPublic FDA data

Disposable Adhesive Surface Electrodes

Primary DI
18054655005070
Brand
Disposable Adhesive Surface Electrodes
Company
SPES MEDICA SPA
Model
CDE0309026
Published
2016-06-21
Public version status
Update
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
18054655005070PrimaryGS10
08054655005073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805465500507018054655005070
08054655005073080546550050738054655005073

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514029771
Device count
120
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18054655007630Disposable Adhesive Surface ElectrodesDENIS020252025-11-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08682250582028Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582035Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582042Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582059Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
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