Catalog Number

5391

Brand Name

5391

Version/Model Number

5391

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 13, 2017

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

K033130

Product Code

DTE

Product Code Name

PULSE-GENERATOR, PACEMAKER, EXTERNAL

Public Device Record Key

f6f3a52f-f7ee-4575-bdd4-d943ce496f04

Public Version Date

September 10, 2021

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-