FDA.reportPublic FDA data

Cadwell

Primary DI
08718375867075
Brand
Cadwell
Company
Technomed Engineering B.V.
Model
302296-000-039
Device description
Disposable NCV Electrode Kit - containing 3x 20mm diameter disc electrode, 1.0m wire, 24sets
Published
2020-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
08718375867082PackageGS124In Commercial Distribution
08718375867075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718375867082087183758670828718375867082
08718375867075087183758670758718375867075

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeAn electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Meter
Outer Diameter20Millimeter

Contacts#

Phone, Email table
PhoneEmail
+31434086868info@technomed.nl

Regulatory Flags#

DUNS number
418415568
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720791375140NeuroguardS23-8372026-06-05
08720791375164NeuroguardS23-9372026-06-05
08720791379032Technomed EuropeTE/C53-10382026-06-03
08720791379049Technomed EuropeTE/C53-10322026-06-03
08720791379063Technomed EuropeTE/K50440-0012026-06-03
08720791379087Technomed EuropeTE/K50440-0152026-06-03
08718375867037Cadwell302296-000-0202020-11-13
08720791378165NeurosignNM-Kit 22026-04-30
08720791378790Technomed Europe8735-00502026-04-30
08720791378806Technomed Europe8735-00602026-04-30
08720791378813Technomed EuropeTE/Q96-8322026-04-30
08720791378837Technomed EuropeBTP2.3-160/12026-04-30
08720791378868Technomed EuropeTE/S50722-003-K2026-04-30
08720791378059Technomed EuropeTE/B50700-0012026-04-29
08720791378073Technomed EuropeTE/B50700-0022026-04-29
08720791378097Technomed EuropeTE/B50700-0062026-04-29
08720791378110Technomed EuropeTE/B50700-0032026-04-29
08720791378134Technomed EuropeTE/B50700-0042026-04-29
08720791378158Technomed EuropeTE/B50700-0052026-04-29
08720791379100Neuralytix NTX-90092026-04-28

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