Catalog Number

81-37000-200

Brand Name

NeuroStar Advanced Therapy System

Version/Model Number

3.X to 3.7 System Upgrade Kit (TouchStar Capable)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201158,K212289

Product Code

OBP

Product Code Name

Transcranial Magnetic Stimulator

Public Device Record Key

5f7ed2b0-74a5-412f-91a9-a91cb11cb448

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-