Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

80502

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

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

-

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

b8593977-c6e2-4ee0-ae5a-61a2f52cba96

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Package DI Number

20809160023713

Quantity per Package

50

Contains DI Package

10809160023716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-