Catalog Number

2224

Brand Name

EZ Trode, 2" square

Version/Model Number

2224

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

bc4871a8-1e1c-495a-85dd-e89b82f6181c

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

10816864020057

Quantity per Package

10

Contains DI Package

00816864020050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case