Duns Number:790780258
Device Description: Astroglide Organix is a personal lubricant for penile and/or vaginal application intended Astroglide Organix is a personal lubricant for penile and/or vaginal application intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex condoms. It is not compatible with polyisoprene, and polyurethane condoms.
Catalog Number
-
Brand Name
Astroglide Organix Gel
Version/Model Number
015594011660
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
-
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
78327ec4-d1ab-4237-957e-ee453c9db58d
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 |