Catalog Number

RBK1011112

Brand Name

iDuo® Femoral Kit

Version/Model Number

RBK101111201

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 2022

Issuing Agency

In HIBCC

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

-

Product Code

NPJ

Product Code Name

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Public Device Record Key

7df528d3-488b-4875-a015-e0583ef7e984

Public Version Date

August 16, 2022

Public Version Number

3

DI Record Publish Date

October 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-