FDA.reportPublic FDA data

Neurosign Disposable Concentric Probe

Primary DI
15060229530667
Brand
Neurosign Disposable Concentric Probe
Company
THE MAGSTIM COMPANY LIMITED
Model
3600-00-TE
Device description
100mm x 1mm electrodes; 1.9m twisted wire with DIN42802 connectors.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060229530667PackageGS110In Commercial Distribution
05060229530660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506022953066715060229530667
05060229530660050602295306605060229530660

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating probe, single-useA sterile, hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG)], by delivering controlled electrical impulses to a specific body site for the measurement of a nerve response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
500375274
Device count
1
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
true
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
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

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Primary DI, Brand, Company table
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