AccessGUDID - DEVICE: MagPro Accessories (05713484030696)

GUDID

Device Identifier (DI) Information

Brand Name: MagPro Accessories
Version or Model: Cable for Ext. Trig with D-sub
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9016E4551
Company Name: Tonica Elektronik A/S

Primary DI Number: 05713484030696
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 566622973 *Terms of Use

Device Description: Cable accessories for MagPro, approved with MagPro R30 in K061645.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
61124	Magnetic neural stimulation system	An assembly of electrically-powered devices intended for the treatment and/or diagnosis 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWF	Stimulator, Electrical, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061645	000

Device Exempt from Premarket Submission: No 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: eb237dfa-1e4f-49cd-9627-96cc9f7fd78b
Public Version Date: December 06, 2022
Public Version Number: 1
DI Record Publish Date: November 28, 2022