Duns Number:790780258
Device Description: Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.
Catalog Number
-
Brand Name
Astroglide Organix Liquid
Version/Model Number
015594011639
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
59ecec80-0eef-4c04-9bf4-0b66abf80f17
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 |