Catalog Number

DS014

Brand Name

StatSeal®

Version/Model Number

DS014

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130324,K130324,K130324

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

3c193cd2-f846-4a27-a6f5-13b51771a350

Public Version Date

April 20, 2022

Public Version Number

3

DI Record Publish Date

January 28, 2022

Package DI Number

00834061006141

Quantity per Package

6

Contains DI Package

00834061000149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton