Catalog Number

AR-8973R-30-130

Brand Name

Arthrex®

Version/Model Number

AR-8973R-30-130

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Public Device Record Key

228e60b4-9133-4259-9a02-c5bbfed090a1

Public Version Date

January 16, 2020

Public Version Number

4

DI Record Publish Date

October 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-