Catalog Number

25M-101

Brand Name

SJM™ Mechanical Heart Valve

Version/Model Number

M-101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 07, 2020

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

LWQ

Product Code Name

HEART-VALVE, MECHANICAL

Public Device Record Key

68ec5ed7-2dbe-45de-a7e7-27224ab2f3be

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

November 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-