Catalog Number

-

Brand Name

DUREX Avanti Bare- 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

59758a5a-7065-4dc5-804c-32e8b3ed0329

Public Version Date

December 13, 2018

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

20302340894559

Quantity per Package

24

Contains DI Package

10302340894552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case