Catalog Number

10UT03

Brand Name

Sustain

Version/Model Number

Sustain Ultra thin condoms (10 pack)

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

K131866,K131866,K131866,K131866

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

f593de82-03f6-4df0-bac8-5fac100016e0

Public Version Date

April 02, 2020

Public Version Number

4

DI Record Publish Date

April 07, 2017

Package DI Number

20856078005058

Quantity per Package

8

Contains DI Package

10856078005051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case