Duns Number:400744553
Device Description: Water-based Personal Lubricant
Catalog Number
-
Brand Name
Arcwave by pjur
Version/Model Number
Arcwave by pjur - 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
352ad446-7591-43c6-8eb8-03ea3c8cba91
Public Version Date
November 10, 2020
Public Version Number
1
DI Record Publish Date
November 02, 2020
Package DI Number
10827160114739
Quantity per Package
6
Contains DI Package
00827160114732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 58 |