Catalog Number

09405566S

Brand Name

NA

Version/Model Number

09.405.566S

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

K183618,K183618

Product Code

KWI

Product Code Name

PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Public Device Record Key

23510815-60ba-4891-a14d-032d951b6e02

Public Version Date

May 02, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-