Catalog Number

OF-2000L

Brand Name

Axius Coronary Shunt

Version/Model Number

OF-2000L

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

K010117,K010117,K010117

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

181fdd32-8b7f-41f9-9cfc-7924ad4653d0

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00607567700707

Quantity per Package

5

Contains DI Package

00607567700703

Package Discontinue Date

May 29, 2018

Package Status

Not in Commercial Distribution

Package Type

5 pack box