FDA.reportPublic FDA data

D25 Alpha B.I. Coil

Primary DI
05060229532411
Brand
D25 Alpha B.I. Coil
Company
THE MAGSTIM COMPANY LIMITED
Model
5220-00
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFStimulator, Electrical, Evoked Response
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
OBPTranscranial Magnetic StimulatorNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060229532411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060229532411050602295324115060229532411

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation placeboAn assembly of electrically-powered devices intended to be used as a non-therapeutic control device (placebo) during clinical investigation trials of magnetic neural stimulation systems. It consists of a device assembly which resembles a magnetic neural stimulation system but only creates a subclinical magnetic field.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
500375274
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
05060229533012Horizon 3.0 Coil Holder5835-00-502025-02-19
05060229533029Horizon 3.0 Camera Stand5471-00-502025-02-19
05060229530448Magstim Rapid² Stimulator3012-002016-09-23
05060229530820Double 70mm Air Film Coil3910-002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B006NVHS102NONENeurovision Medical Products, Inc.GWF2025-12-18
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
00190376530024SafeOp 3ALPHATEC SPINE, INC.GWF2024-11-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTST2Nerveana+®Neurovision Medical Products, Inc.GWF2023-12-04
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P7T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P852Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P8T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPIC61Nerveäna+®Neurovision Medical Products, Inc.GWF2023-04-11