Duns Number:618973077
Device Description: Wet Essential95 Personal Lubricant is a personal lubricant, for penile and/or vaginal appl Wet Essential95 Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturizeand lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible withpolyurethane condoms.
Catalog Number
42231
Brand Name
Wet Essential95
Version/Model Number
42231
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
-
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
191d839d-6a65-4541-b3a0-de2493a2685c
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |