Duns Number:400744553
Device Description: Silicone-based Personal Lubricant
Catalog Number
-
Brand Name
pjur Light
Version/Model Number
pjur Light 30 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
K133336,K133336,K133336
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
c22e0c91-88d7-4fe6-b5ae-1e3f862527bf
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
May 01, 2017
Package DI Number
40827160111982
Quantity per Package
28
Contains DI Package
10827160111981
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 |