Catalog Number

-

Brand Name

CARBOMEDICS ORBIS

Version/Model Number

A1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P900060,P900060,P900060,P900060,P900060,P900060,P900060,P900060,P900060,P900060,P900060

Product Code

LWQ

Product Code Name

HEART-VALVE, MECHANICAL

Public Device Record Key

7e16c0ee-79f0-41b1-8ce7-b150f2d2a47c

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

July 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-