Catalog Number

-

Brand Name

DUREX RealFeel Non-Latex Condom

Version/Model Number

Condom

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

K072169,K072169,K072169,K072169

Product Code

MOL

Product Code Name

Condom, synthetic

Public Device Record Key

f4c9af96-3ae0-481b-9ded-bf7c807f7257

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Package DI Number

20302340908058

Quantity per Package

3

Contains DI Package

10302340908051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case