Catalog Number

PACE 203H LOANER

Brand Name

PACE 203H

Version/Model Number

PACE 203H LOANER

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

K020896

Product Code

DTE

Product Code Name

PULSE-GENERATOR, PACEMAKER, EXTERNAL

Public Device Record Key

149f72c0-b0ac-4fb6-b823-741cabbfe8ce

Public Version Date

October 05, 2018

Public Version Number

4

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-