Catalog Number

-

Brand Name

JO Premium Original 16oz/480ml

Version/Model Number

40031

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

-

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

d28698ee-53f1-449a-8c46-b15506a5ebf8

Public Version Date

September 09, 2022

Public Version Number

4

DI Record Publish Date

May 21, 2018

Package DI Number

B362400311

Quantity per Package

12

Contains DI Package

B362400310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-