Catalog Number

12240-02

Brand Name

pjur Original

Version/Model Number

pjur Original 500 ml - USA

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

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

K133233,K133233,K133233

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

a5ba146f-cad2-4271-8219-bc0a99ba3833

Public Version Date

August 31, 2022

Public Version Number

6

DI Record Publish Date

May 01, 2017

Package DI Number

40827160112293

Quantity per Package

15

Contains DI Package

10827160112292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case