Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

31-274

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)

Yes

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

HIS

Product Code Name

CONDOM

Public Device Record Key

048cb1bc-1834-44f2-b267-8f91d20305fd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Package DI Number

50749756029587

Quantity per Package

50

Contains DI Package

00749756029582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case