FDA.reportPublic FDA data

Neurosign Disposable Single Electrode

Primary DI
05060229530349
Brand
Neurosign Disposable Single Electrode
Company
THE MAGSTIM COMPANY LIMITED
Model
1705-00-TE
Device description
20mm x 0.3mm needle electrode; 1m cable with TP DIN42802 connector
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060229530346PackageGS120Not in Commercial Distribution
05060229530349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506022953034615060229530346
05060229530349050602295303495060229530349

GMDN Terms#

Term, Definition table
TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+441994240798QA.RA@magstim.com
+441994241111salesoperations@magstim.com

Regulatory Flags#

DUNS number
500375274
Device count
1
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
05060229533074Horizon 3.0 MEP Pod6261-002024-10-30
05060229533081Horizon 3.0 Inspire Mainframe6251-002024-10-30
05060229532701Horizon 3.0 PSU (Power Supply Unit)5801-002021-12-21
05060229532251HORIZON™ MT Remote Coil4990-002017-11-22
05060229532268HORIZON™ Air Film Coil4980-002017-11-22
05060229532299HORIZON™ User Interface5048-002017-11-22
05060229530455Magstim Rapid² Power Supply Single Module3013-002016-09-23
05060229530479Magstim Rapid² Power Supply Dual Module3014-002016-09-23
05060229531476Magstim Plus1 Module4040-002025-07-10
05060229531513Magstim D70 Alpha Coil4150-002025-07-10
05060229531520Magstim D70 Alpha Flat Coil (Coated)4170-002025-07-10
05060229531803Magstim D60 Alpha Flat Coil (Coated)4190-002025-07-10
05060229531926Magstim Plus1 Module 115V4040-US2025-07-10
05060229531964Magstim D60α Branding Iron (Coated) Coil4189-002025-07-10
05060229531971Magstim D70α Branding Iron (Coated) Coil4510-002025-07-10
05060229530868Magstim Double 70mm Air Film Coil3950-002025-02-19
05060229532411D25 Alpha B.I. Coil5220-002025-02-19
05060229533012Horizon 3.0 Coil Holder5835-00-502025-02-19
05060229533029Horizon 3.0 Camera Stand5471-00-502025-02-19
05060229530448Magstim Rapid² Stimulator3012-002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
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
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08033315122466BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122541BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122565BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122589BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122602BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122626BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122640BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122664BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122688BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08718375861714Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861721Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861738Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861745Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861752Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861769Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861899Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22