Catalog Number

-

Brand Name

Painmaster

Version/Model Number

Bell Shaped Snap Tens Electrode

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

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

9a346d80-9ddd-4fee-b915-d2efe6680453

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

20781604000132

Quantity per Package

40

Contains DI Package

10781604000135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case