Catalog Number

4480-12

Brand Name

NTERFACE

Version/Model Number

4480-12

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

2f2e817c-4338-4b64-a95c-11a0307ef165

Public Version Date

July 22, 2020

Public Version Number

1

DI Record Publish Date

July 14, 2020

Package DI Number

10858150000473

Quantity per Package

48

Contains DI Package

00858150000476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case