Catalog Number

-

Brand Name

Electrodes

Version/Model Number

13-14000-1002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K020468,K020468

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

4887f81f-7478-4025-b258-d38b9a020896

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

10817377021364

Quantity per Package

10

Contains DI Package

00817377021367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-