Catalog Number

4120-48RL

Brand Name

NTERFACE

Version/Model Number

4120-48RL

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

1eae9b62-60a0-4789-9721-48c754017268

Public Version Date

July 22, 2020

Public Version Number

1

DI Record Publish Date

July 14, 2020

Package DI Number

10858150000503

Quantity per Package

24

Contains DI Package

00858150000506

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case