Catalog Number

-

Brand Name

Open Pivot™

Version/Model Number

501DA18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2019

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

P990046

Product Code

LWQ

Product Code Name

HEART-VALVE, MECHANICAL

Public Device Record Key

15066d73-eeac-4c71-aceb-c6f731797162

Public Version Date

September 12, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-