Catalog Number

-

Brand Name

EnVeo™ R

Version/Model Number

LS-ENVEOR23US

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

P130021,P130021

Product Code

NPT

Product Code Name

Aortic valve, prosthesis, percutaneously delivered

Public Device Record Key

91a7485d-0996-4470-8f6e-5725851c548e

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

June 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-