Catalog Number

31140612

Brand Name

Devon

Version/Model Number

31140612

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)

-

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

a95d6930-4ebe-47bb-baa1-60f382dceec2

Public Version Date

May 22, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884527018901

Quantity per Package

30

Contains DI Package

20884527018908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE