AccessGUDID - DEVICE: NeuroStar System Software (00850005944119)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroStar System Software
Version or Model: Version 3.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83-00054-000
Company Name: NEURONETICS, INC.

Primary DI Number: 00850005944119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134960348 *Terms of Use

Device Description: System Software for NeuroStar Mobile Console

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):	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
OBP	Transcranial Magnetic Stimulator
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201158	000
K212289	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: acc1b3e2-c0f4-4ed6-a717-98c5010ef54a
Public Version Date: March 01, 2023
Public Version Number: 1
DI Record Publish Date: February 21, 2023