Duns Number:428453013
Device Description: HYALO GYN® is a personal lubricant, for penile and/or vaginal application intended to mois HYALO GYN® 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 condoms: lubricated/nonlubricated latex, lubricated polyurethane, lubricated natural skin.
Catalog Number
379604
Brand Name
HYALO GYN Vaginal Hydrating Gel, 10g Tube
Version/Model Number
379604
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
Yes
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
K094039
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
15edd247-ac13-4200-bb60-91cbf48b855d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 01, 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. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 5 |