Catalog Number

KV1016823

Brand Name

Univ Full Back w (8) 2x3 electrodes

Version/Model Number

KV1016823

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

K053214

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

c083b941-02bb-49d5-bf30-d33c99e98fc8

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

December 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-