Duns Number:400744553
Device Description: Water-based Personal Lubricant
Catalog Number
11860-02
Brand Name
pjur Woman Nude
Version/Model Number
pjur Woman Nude 100 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,K200730,K010199,K200730,K010199,K200730
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
897307f9-b017-4ece-9bab-65ac034d8be6
Public Version Date
August 31, 2022
Public Version Number
7
DI Record Publish Date
May 01, 2017
Package DI Number
40827160112026
Quantity per Package
12
Contains DI Package
10827160112025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 58 |