Catalog Number

20-001

Brand Name

Dukal

Version/Model Number

20-001

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)

-

Over the Counter (OTC)

Yes

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

71af3b2b-1fda-4d69-b342-93aeb606abe4

Public Version Date

May 23, 2022

Public Version Number

9

DI Record Publish Date

October 30, 2017

Package DI Number

20665973006738

Quantity per Package

6

Contains DI Package

10665973006731

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case