Exsens Raspberry gel lubrifiant intime
Basic Information
- Brand Name
- Exsens Raspberry gel lubrifiant intime
- Primary DI
- 03701411600021
- Version / Model
- 1
- Company Name
- NEO COSMETIQUE
- Labeler DUNS
- 267777424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-04
- Public Version
- 1
- Public Version Date
- 2020-03-12
- Public Version Status
- New
- Public Device Record Key
- dfbb04c0-80f0-4ad2-b769-3cce555b646f
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701411600021 | GS1 |
Customer Contacts
- Phone
- +33149465105
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163674 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius