Catalog Number

ABS-4012

Brand Name

Arthrex®

Version/Model Number

ABS-4012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130350

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

2dc98b34-b9bc-4994-bbc8-6cd4caa242f9

Public Version Date

June 19, 2020

Public Version Number

9

DI Record Publish Date

February 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-