Catalog Number

-

Brand Name

NA

Version/Model Number

5392

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

K132924,K150246

Product Code

DTE

Product Code Name

PULSE-GENERATOR, PACEMAKER, EXTERNAL

Public Device Record Key

5c8cfd1d-b547-47c7-a8e2-0232b3764c65

Public Version Date

October 05, 2018

Public Version Number

4

DI Record Publish Date

November 13, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-