Catalog Number

-

Brand Name

Stimulator Cart

Version/Model Number

5290-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

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

K182853

Product Code

OBP

Product Code Name

Transcranial Magnetic Stimulator

Public Device Record Key

92597e8c-0cc3-4a4c-a530-943a8cff2d37

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-