Duns Number:428453013
Device Description: HYALO GYN® Made without parabens is a personal lubricant for vaginal application intended HYALO GYN® Made without parabens is a personal lubricant for 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 polyisoprene condoms.
Catalog Number
179704
Brand Name
HYALO GYN Vaginal Hydrating Gel, 30g Tube - Made without Parabens
Version/Model Number
179704
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
d5e5f95f-8949-41a2-966a-7e718bc0d490
Public Version Date
April 02, 2021
Public Version Number
1
DI Record Publish Date
March 25, 2021
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. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 5 |