FDA.report

Magstim Rapid² Mains Lead Filter 115V

Primary DI
05060229532176
Brand
Magstim Rapid² Mains Lead Filter 115V
Company
THE MAGSTIM COMPANY LIMITED
Model
3801-01
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GWFStimulator, Electrical, Evoked Response

Product Code Classifications

CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060229532176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060229532176050602295321765060229532176

GMDN Terms

TermDefinition
Magnetic neural stimulation system, stationaryA stationary assembly of mains electricity (AC-powered) devices intended for the treatment of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools to enhance the therapeutic effect.

Sterilization Methods

Method

Contacts

PhoneEmail
+441994241111salesoperations@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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
05060229533074Horizon 3.0 MEP Pod6261-002024-10-30
05060229533081Horizon 3.0 Inspire Mainframe6251-002024-10-30
05060229533005Horizon 3.0 Interface Unit 5445-00-502024-05-09
05060229533036Horizon 3.0 ez Cool Coil 5620-00-502024-05-09
05060229532107D70 Alpha Sham Coil4334-002024-03-11
05060229532923StimGuide Pro Pointer Tool6438-002024-01-01
05060229532930StimGuide Pro Head Reference5968-002024-01-01
05060229532947StimGuide Pro MT Coil Tracker Tool5967-012024-01-01
05060229532954StimGuide Pro E-z Coil Tracker Tool5966-102024-01-01

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