Catalog Number

13969-02

Brand Name

pjur AQUA Aloe

Version/Model Number

pjur AQUA Aloe 2ml - 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

K200527,K200527,K200527

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

aeef2f47-5b6b-416a-86d6-9a80e2a8c11a

Public Version Date

August 31, 2022

Public Version Number

2

DI Record Publish Date

March 22, 2022

Package DI Number

10827160115187

Quantity per Package

50

Contains DI Package

00827160115180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack