Catalog Number

-

Brand Name

DONJOY

Version/Model Number

11-4000-0-06000

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"

Yes

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

IKK

Product Code Name

SYSTEM, ISOKINETIC TESTING AND EVALUATION

Public Device Record Key

ffcf6599-1439-4994-8bf3-df04707657df

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

April 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-