Catalog Number

4LUWI

Brand Name

Luwi

Version/Model Number

4LUWI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 30, 2025

Issuing Agency

In HIBCC

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

P080002,P080002

Product Code

MOL

Product Code Name

Condom, Synthetic

Public Device Record Key

91ad0308-1604-4c45-92d1-b8721d5dde05

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-