Catalog Number

-

Brand Name

Paxeon BiPolar Head

Version/Model Number

PR111-21-2852

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

K133370

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Public Device Record Key

745a4c5c-37c8-4f26-8c84-8b0a2430f9c7

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

December 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-