Catalog Number

80XL04

Brand Name

Sustain Natural

Version/Model Number

Sustain XL w/ ribs & dots condoms (144 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

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

76f4db78-f6ea-4519-89e2-42201af1644a

Public Version Date

April 02, 2020

Public Version Number

2

DI Record Publish Date

June 06, 2018

Package DI Number

20856078005362

Quantity per Package

8

Contains DI Package

10856078005365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case