Catalog Number

-

Brand Name

Electrodes

Version/Model Number

13-40000-0001

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

Yes

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

95418afa-3418-427c-89b8-cc5a25b0eda7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

10817377021418

Quantity per Package

50

Contains DI Package

00817377021411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-