Catalog Number

-

Brand Name

KY True Feel Premium Silicone 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

K173504,K173504,K173504

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

cde32357-c462-48de-a137-cbc26caf49f1

Public Version Date

November 27, 2019

Public Version Number

1

DI Record Publish Date

November 19, 2019

Package DI Number

20067981087899

Quantity per Package

4

Contains DI Package

10067981087892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case