Catalog Number

-

Brand Name

Avalus™

Version/Model Number

7420

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DTJ

Product Code Name

HOLDER, HEART-VALVE, PROSTHESIS

Public Device Record Key

45cff825-dec4-413c-b52d-7c2d4ad79155

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-