Catalog Number

HP-PRL5

Brand Name

CardioGenesis

Version/Model Number

HP-PRL5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 08, 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"

Yes

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

P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029,P970029

Product Code

MNO

Product Code Name

System, Laser, Transmyocardial Revascularization

Public Device Record Key

2785ad9d-59a7-435d-9e0b-de09dedf4bf9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-