Catalog Number

WSO001

Brand Name

WoundSeal®

Version/Model Number

WSO001

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

K070520,K080210,K070520,K080210

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

bf33e5a3-0e2e-4097-8031-982c3d13d4bf

Public Version Date

April 20, 2022

Public Version Number

3

DI Record Publish Date

January 28, 2022

Package DI Number

00834061006318

Quantity per Package

24

Contains DI Package

00834061000019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case