Catalog Number

-

Brand Name

ClosureFast™

Version/Model Number

KC-24X18

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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

8d7eec49-b3e8-4fcf-bc4e-78649656347c

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Package DI Number

20884521140339

Quantity per Package

10

Contains DI Package

10884521140332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK