Catalog Number

-

Brand Name

SureStop

Version/Model Number

19x19mm

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

8e5ca814-b822-4f05-b7c0-9bcd7cabc17b

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 26, 2020

Package DI Number

26940610100500

Quantity per Package

200

Contains DI Package

16940610100503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton