Catalog Number

-

Brand Name

Magstim

Version/Model Number

5797-00-00

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

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

fd4d54ad-a9af-4baa-b306-82b3899c1847

Public Version Date

June 25, 2021

Public Version Number

1

DI Record Publish Date

June 17, 2021

Package DI Number

08718375868065

Quantity per Package

10

Contains DI Package

08718375868072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-