Catalog Number

-

Brand Name

JO Agape - Warming - Lubricant 2 floz / 60 mL

Version/Model Number

42009

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)

-

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

K200208,K200208

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

ed17bf38-9c05-4a6e-9e74-d150443ceaa8

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

10796494001032

Quantity per Package

12

Contains DI Package

00796494001035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-