Catalog Number

-

Brand Name

LifeStyles Ultra Sensitive Platinum

Version/Model Number

0179

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163107,K163107,K163107,K163107

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

d0d41710-04d1-4e5d-b70a-2a20a4a363d2

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

May 08, 2019

Package DI Number

30070907201795

Quantity per Package

6

Contains DI Package

10070907201791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case