Catalog Number

-

Brand Name

TENS Electrode Set

Version/Model Number

S1000E

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)

-

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

21df2146-7882-4421-997b-153594e84a77

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

April 11, 2017

Package DI Number

20754756740010

Quantity per Package

8

Contains DI Package

10754756740013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-