Catalog Number

-

Brand Name

Lush

Version/Model Number

Lush 8.5 fl oz Water Based 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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051295,K051295

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

a14206b7-6e96-4430-87f2-e044184ad1fa

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

April 21, 2017

Package DI Number

30864785000201

Quantity per Package

12

Contains DI Package

00864785000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case