Catalog Number

KWTS22-MFR

Brand Name

TENSTRODE

Version/Model Number

KWTS22-MFR

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012463,K012463,K012463,K012463

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

9d950dd3-a11a-4fc7-843a-4f257cdd8238

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

November 21, 2019

Package DI Number

30850209007000

Quantity per Package

400

Contains DI Package

00850209007009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE