Catalog Number

-

Brand Name

Subchondroplasty® Knee Kit

Version/Model Number

402.202

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

-

Product Code

-

Product Code Name

-

Public Device Record Key

0aab59dd-8003-4ca9-8af8-bccd8c313b83

Public Version Date

August 23, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

00889024205291

Quantity per Package

4

Contains DI Package

00889024205260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-