Catalog Number

-

Brand Name

CARBOMEDICS ORBIS

Version/Model Number

M2

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

a2606c1e-c7bf-4e76-ae68-6f1741036576

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

-