Catalog Number

KWF1315-TP, KWF1315-MFR

Brand Name

TENSPRODUCTS/TENSTRODE

Version/Model Number

KWF1315

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

K083302,K083302,K083302

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

96951957-741b-4904-889b-1ae04f20cb4a

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 12, 2018

Package DI Number

20816924020062

Quantity per Package

320

Contains DI Package

00816924020068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case