Catalog Number

-

Brand Name

KY Personal Lubricant Jelly

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

K201186,K201186,K201186

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

b5ec4bb5-44c1-4599-9dc2-381bfd0c4a88

Public Version Date

April 12, 2022

Public Version Number

1

DI Record Publish Date

April 04, 2022

Package DI Number

10067981089124

Quantity per Package

4

Contains DI Package

00067981089127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton