Catalog Number

9204-1004

Brand Name

Bipolar II™

Version/Model Number

9204-1004

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

-

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

K110245,K123550,K132207,K152439

Product Code

KWY

Product Code Name

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

Public Device Record Key

cc5c9772-0c7b-47df-bde3-7674a7b300f3

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-