Duns Number:790780258
Device Description: Astroglide Natural is a personal lubricant for penile and/ or vaginal application, intende Astroglide Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.
Catalog Number
-
Brand Name
Astroglide Natural Liquid Personal Lubricant
Version/Model Number
015594010946
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
K141581
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
217de9a2-12b5-46b8-b9dc-b42ee3ddf5a7
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
September 13, 2016
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 |