Catalog Number

06003

Brand Name

Kimono

Version/Model Number

MicroThin Plus Aqua Lube

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

K113686,K113686,K113686,K113686

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

3734d12c-43a0-49c3-8214-f7a3d2e4574d

Public Version Date

November 11, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

10116169060032

Quantity per Package

8

Contains DI Package

20116169060039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON