Duns Number:091123992
Device Description: Vagisil Moisturizing Gel is an Over-The-Counter personal lubricant, intended to both moist Vagisil Moisturizing Gel is an Over-The-Counter personal lubricant, intended to both moisturize and lubricate and is presented in 8 pre filled applicators of 0.20 oz (5.9 g) each for easy use. The device is sold in a carton. REFERENCE FDA UDI ALTERNATIVE NUMBER: UDI-A160001
Catalog Number
Item Code: 6050
Brand Name
Vagisil Prohydrate Natural Feel Internal Vaginal Moisturizing Gel
Version/Model Number
Item Code: 6050
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
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
-
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
101b7aa5-d843-485f-93c6-af74f37982e7
Public Version Date
August 07, 2020
Public Version Number
4
DI Record Publish Date
September 26, 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. | 1 |