Catalog Number

13850-02

Brand Name

pjur Mini Collection - 4 x 10 ml - USA

Version/Model Number

pjur Mini Collection - 4 x 10 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

K010199,K133233,K141913,K200527,K200730,K010199,K133233,K141913,K200527,K200730

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

5ad1cf7b-2260-4991-a3f2-0b274fe776e0

Public Version Date

September 01, 2022

Public Version Number

4

DI Record Publish Date

June 18, 2020

Package DI Number

10827160114289

Quantity per Package

6

Contains DI Package

00827160114282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack