Catalog Number

-

Brand Name

pjur Aqua

Version/Model Number

pjur Aqua 2 ml - USA (50 pcs.)

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

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

b3c71b44-eb97-4f06-8a5b-4a0b577a4b14

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

January 25, 2017

Package DI Number

40827160100252

Quantity per Package

20

Contains DI Package

00827160100254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case