Catalog Number

-

Brand Name

KY Intense Pleasure Gel

Version/Model Number

Personal Lubricant

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

-

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

K151884,K151884,K151884

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

27fddd99-8197-4000-878a-bb5106c4fa7a

Public Version Date

November 14, 2019

Public Version Number

1

DI Record Publish Date

November 06, 2019

Package DI Number

20067981972867

Quantity per Package

6

Contains DI Package

10067981972860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case