FDA.reportPublic FDA data

Cadwell

Primary DI
08720791375911
Brand
Cadwell
Company
Technomed Engineering B.V.
Model
302881-000
Device description
The kit consists of:• 1x Ground Electrode 40x50mm (302299-000-078),• 2x Twisted Pair Surface Electrode 20x25mm disk (302880-000),• White Subdermal Needle (302864-000), and• 8x Twisted Subdermal Needles (white or black+ red, blue, purple, orange) (302868-000).
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
GXZElectrode, Needle
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
GXZElectrode, NeedleNeurology2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720791375911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720791375911087207913759118720791375911

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418415568
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
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
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
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
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
00816312024401RHYTHMLINK INTERNATIONAL, LLCRHYTHMLINK INTERNATIONAL, LLCGXY2022-01-12
08600053881032EpilogEpitel, Inc.GXY2022-01-01
08600053881650REMIEpitel, Inc.GXY2022-01-01
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08718375861707Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08033315122299BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122312BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122336BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122350BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122374BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122398BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122411BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122442BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122466BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122541BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04