Catalog Number

EX3151

Brand Name

SJM™

Version/Model Number

EX3151

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

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

P950022

Product Code

NVY

Product Code Name

Permanent defibrillator electrodes

Public Device Record Key

169a4cbd-912b-470b-9ea3-22e75b7c4c48

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

April 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-