Catalog Number

Stellite N9

Brand Name

Kennametal Stellite

Version/Model Number

Stellite N9

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EJH

Product Code Name

Alloy, Metal, Base

Public Device Record Key

ca4205a1-aa63-42fe-abac-3c88f9c8ac8d

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

06972796430047

Quantity per Package

20

Contains DI Package

06972796430023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton