Identity
- Trade Name
- Exsens Raspberry gel lubrifiant intime FDA UDI
- Generic Name
- Vaginal lubricant FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701411600021 FDA UDI
- 510(k) Number
- K163674 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- Vaginal lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal lubricant
Exsens Raspberry gel lubrifiant intime by Neo Cosmetique — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163674 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neo Cosmetique
Sources (1)
- FDA UDI dfbb04c0-80f0-4ad2-b769-3cce555b646f 36 fields · synced Jun 1, 2026