Catalog Number

AR-6431

Brand Name

Arthrex®

Version/Model Number

AR-6431

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

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

10aed335-7ee5-49ff-a4b1-1b0cfe8b29fb

Public Version Date

March 02, 2022

Public Version Number

19

DI Record Publish Date

February 15, 2017

Package DI Number

10888867039336

Quantity per Package

20

Contains DI Package

00888867039339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box