Catalog Number

-

Brand Name

SenStar Treatment Link

Version/Model Number

81-70000-000

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

Yes

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

-

Product Code

OBP

Product Code Name

Transcranial Magnetic Stimulator

Public Device Record Key

cedde0c8-ca8b-4a44-bf70-5bb0e5f64aa2

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Package DI Number

10850005944222

Quantity per Package

5

Contains DI Package

00850005944225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack