Catalog Number

AR-8500BL

Brand Name

Arthrex®

Version/Model Number

AR-8500BL

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

GFF

Product Code Name

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

f7fd29eb-106f-4793-bf9b-cfeba61d64e0

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

August 03, 2018

Package DI Number

10888867043746

Quantity per Package

5

Contains DI Package

00888867043749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box