Catalog Number

03012

Brand Name

Kimono

Version/Model Number

MAXX Large Flare

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K941258,K941258,K941258,K941258

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

d8c2cde2-bda4-44e2-9785-9c5b6672ff89

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

10016169030120

Quantity per Package

8

Contains DI Package

20016169030127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON