Catalog Number

KWTS2-MFR, KWTS2-JETT

Brand Name

TENSPRODUCTS/TENSTRODE

Version/Model Number

KWTS2-TP

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

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

4b17c3d8-42c5-41df-9343-b256b7fa4afd

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 12, 2018

Package DI Number

30816924020182

Quantity per Package

320

Contains DI Package

00816924020181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case