Catalog Number

-

Brand Name

PERCEVAL S

Version/Model Number

ICV1242

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

P150011

Product Code

LWR

Product Code Name

heart-valve, non-allograft tissue

Public Device Record Key

8e1a3f54-7e25-41b0-9cdb-2e82f2be0b3f

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

June 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-