Catalog Number

RKNLPCWB1

Brand Name

Rheo Knee

Version/Model Number

RKNLPCWB1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ISW

Product Code Name

ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Public Device Record Key

0656468b-94d0-44fa-b579-2e761f48d9a4

Public Version Date

June 18, 2018

Public Version Number

1

DI Record Publish Date

May 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-