Duns Number:790780258
Device Description: Astroglide Quiver is a water-based, water-soluble, natural rubber latex condom compatibile Astroglide Quiver is a water-based, water-soluble, natural rubber latex condom compatibile personal lubricant with a slight warming effect when applied to the body.Astroglide® Quiver is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.
Catalog Number
-
Brand Name
Astroglide Quiver
Version/Model Number
015594011967
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
-
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
K041432
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
da2e48b7-f3d7-43c9-a389-e4578c690fc7
Public Version Date
February 23, 2022
Public Version Number
1
DI Record Publish Date
February 15, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |