Catalog Number

5300203

Brand Name

ezPad MRI

Version/Model Number

large

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

-

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

ed5cdf19-5545-406a-a2fb-ba68ea4d76f7

Public Version Date

April 17, 2020

Public Version Number

2

DI Record Publish Date

October 23, 2018

Package DI Number

EMIP53002031

Quantity per Package

25

Contains DI Package

EMIP53002030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-