Magstim TMS Patient Cap (Size Medium)

Basic Information

• Brand Name: Magstim TMS Patient Cap (Size Medium)
• Primary DI: 05060229532763
• Version / Model: 5771-00
• Company Name: THE MAGSTIM COMPANY LIMITED
• Labeler DUNS: 500375274
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-31
• Public Version: 1
• Public Version Date: 2022-02-08
• Public Version Status: New
• Public Device Record Key: a38ebc57-6c7f-4223-9be6-6e7f606edd93

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYF	Cap, Surgical	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63874	Head marking cap	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060229532760	GS1		10	In Commercial Distribution
Primary	05060229532763	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]