Duns Number:267777424
Device Description: INTENDED USE This Exsens product is a water based intimate lubricant intended for penile a INTENDED USE This Exsens product is a water based intimate lubricant intended for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.DIRECTIONS Apply desired amount. Reapply as desired. This product is compatible with natural rubber latex condoms and polyisoprene male condoms. This product is not compatible with polyurethane condoms. WARNING This product is not a contraceptive and does not contain spermicide. Avoid contact with the eyes. Keep out of reach of children. Use on healthy intimate mucous. If irritation or discomfort occurs discontinue use immediately and consult a physician. Very slippery on surfaces, clean spills immediately.
Catalog Number
-
Brand Name
Exsens Aloe Vera Gel lubrifiant intime
Version/Model Number
1
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163674
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
337b0989-2df3-4dc0-ac3c-1f332a667ad9
Public Version Date
March 12, 2020
Public Version Number
1
DI Record Publish Date
March 04, 2020
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. | 2 |