Catalog Number

-

Brand Name

N/A

Version/Model Number

EP2020TC2A

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

44f98ac9-9232-48bb-8404-bb404b67783f

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 17, 2016

Package DI Number

80092237619137

Quantity per Package

8

Contains DI Package

30092237619132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA