Catalog Number

-

Brand Name

KY Tingling Lubricant

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

K072236,K072236,K072236

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

6612c539-46cd-41e0-8dcd-10e25a93184a

Public Version Date

October 24, 2019

Public Version Number

2

DI Record Publish Date

April 22, 2019

Package DI Number

10067981963493

Quantity per Package

3

Contains DI Package

00067981963496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton