Catalog Number

383871

Brand Name

PRO-Kinetic Energy

Version/Model Number

3.5/13/140

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

-

Product Code

MAF

Product Code Name

STENT, CORONARY

Public Device Record Key

3587f17e-4cea-49c9-9cb6-a2f506f36834

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

March 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-