Catalog Number

-

Brand Name

Lulu Art Series Water Based Lubricant

Version/Model Number

3 x 8 fl oz (250ml)

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161585

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

76309cab-f998-4e4e-ba20-e5c732b47b4a

Public Version Date

June 25, 2021

Public Version Number

4

DI Record Publish Date

June 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-