Catalog Number

-

Brand Name

3f®

Version/Model Number

1000-25

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 29, 2016

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

P060025

Product Code

LWR

Product Code Name

heart-valve, non-allograft tissue

Public Device Record Key

ea9b6177-7ca1-4d3d-a1b2-1b0e5db4413f

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-