Catalog Number

AR-7215

Brand Name

Arthrex®

Version/Model Number

AR-7215

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

3b47dda1-0b7b-40f1-8149-c0dd84e00269

Public Version Date

July 28, 2021

Public Version Number

9

DI Record Publish Date

December 07, 2017

Package DI Number

10888867207933

Quantity per Package

12

Contains DI Package

00888867207936

Package Discontinue Date

July 27, 2021

Package Status

Not in Commercial Distribution

Package Type

Box