Catalog Number

PFP1X10

Brand Name

PhotoFix Decellularized Bovine Pericardium

Version/Model Number

PFP1X10

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

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

PSQ

Product Code Name

Intracardiac Patch Or Pledget, Biologically Derived

Public Device Record Key

4e0ca6c1-4580-4d30-8327-132c290cf8cf

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-