Catalog Number

3474

Brand Name

PremierPro

Version/Model Number

3474

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"

Yes

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

OMD

Product Code Name

Cutaneous Tissue Adhesive With Mesh

Public Device Record Key

eea068f4-ed85-41b0-8d4d-97fe11a6d645

Public Version Date

May 07, 2020

Public Version Number

1

DI Record Publish Date

April 29, 2020

Package DI Number

10811220032873

Quantity per Package

2

Contains DI Package

00811220032876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box