FDA.reportPublic FDA data

Disposable EMG needle electrodes

Primary DI
08054655008418
Brand
Disposable EMG needle electrodes
Company
SPES MEDICA SPA
Model
DSFN380453707
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054655008415PrimaryGS10
08054655008418Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805465500841518054655008415
08054655008418080546550084188054655008418

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
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
18054655007630Disposable Adhesive Surface ElectrodesDENIS020252025-11-21
18054655007623Disposable Adhesive Surface ElectrodesDENIS020252016-06-17
18054655008415Disposable EMG needle electrodesDSFN3804537072025-03-03
18054655023357Disposable EMG needle electrodesDSFN3804525062025-03-03
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791370206NeuroguardTechnomed Engineering B.V.IKT2023-01-02
08720791370220NeuroguardTechnomed Engineering B.V.IKT2023-01-02
08718375869062AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869123AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869154AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869185AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869215AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869277AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869604Neurosign V4Technomed Engineering B.V.IKT2022-07-04
08718375869628Neurosign V4Technomed Engineering B.V.IKT2022-07-04
08718375869871Neurosign V4Technomed Engineering B.V.IKT2022-04-14
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08718375867914Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24