Duns Number:428453013
Device Description: vH Essentials Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered vH Essentials Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. vH Essentials Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Catalog Number
-
Brand Name
vH Essentials Moisturizing Vaginal Suppositories
Version/Model Number
5396
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
672c9486-7adf-4501-b6df-91116d05c80b
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 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. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 5 |