Catalog Number

13985-02

Brand Name

pjur AQUA Naked

Version/Model Number

pjur AQUA Naked, 100ml 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,K010199,K010199

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

f00836f4-f9b1-4e1a-a681-0957bf434202

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

10827160115422

Quantity per Package

12

Contains DI Package

00827160115425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack