FDA.reportPublic FDA data

Magstim TMS Patient Cap (Size Small)

Primary DI
15060229532753
Brand
Magstim TMS Patient Cap (Size Small)
Company
THE MAGSTIM COMPANY LIMITED
Model
5770-00
Device description
The Magstim TMS Patient Caps are non-sterile medical device accessories, intended to aid in landmark registration during TMS procedures. The user will mark the cap to record various landmarks associated with the treatment or therapy they are conducting.
Published
2022-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060229532753PackageGS110In Commercial Distribution
05060229532756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506022953275315060229532753
05060229532756050602295327565060229532756

GMDN Terms#

Term, Definition table
TermDefinition
Head marking capA non-sterile head covering designed as a cap intended to be worn on the head of a patient to allow a healthcare professional to mark specific reference points on the head during a procedure [e.g., transcranial magnetic stimulation (TMS)] as an alternative to marking the scalp directly or to avoid cutting the patient’s hair. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844 624 7846sales@magstim.com

Regulatory Flags#

DUNS number
500375274
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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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