Catalog Number

EEM3RND

Brand Name

Eagle Electrode Manufacturing Self Adhering Electrodes

Version/Model Number

EEM3RND

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

K030800

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

0e7a11d9-58ed-4a65-b803-7fe6d8cdb857

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-