Catalog Number

FG0008-04

Brand Name

ReTAP® Cardiovascular Patch

Version/Model Number

FG0008-04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

DXZ

Product Code Name

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Public Device Record Key

26e5ca46-8af5-43e7-b4f1-7087d8d93def

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-