AccessGUDID - DEVICE: Magstim TMS Patient Cap (Size Small) (05060229532756)

GUDID

Device Identifier (DI) Information

Brand Name: Magstim TMS Patient Cap (Size Small)
Version or Model: 5770-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE MAGSTIM COMPANY LIMITED

Primary DI Number: 05060229532756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 500375274 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYF	Cap, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e4776e62-d797-46e8-a779-a38d0ba90714
Public Version Date: February 08, 2022
Public Version Number: 1
DI Record Publish Date: January 31, 2022