Catalog Number

-

Brand Name

Micropace

Version/Model Number

EPS320_StimCor CardiacStimulator

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

K011826

Product Code

JOQ

Product Code Name

Generator, Pulse, Pacemaker, External Programmable

Public Device Record Key

f819e8b8-bb4b-485c-a3da-ceefe2b67ed5

Public Version Date

January 13, 2021

Public Version Number

5

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-