Catalog Number

H403023

Brand Name

EP-4™

Version/Model Number

H403023

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

K092913

Product Code

JOQ

Product Code Name

Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)

Public Device Record Key

0912af4b-0216-408a-9502-8ba35e906dbe

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-