Identity
- Trade Name
- REVAREE FDA UDI
- Generic Name
- Vaginal mucosa protection dressing FDA UDI
- Device Name
- THE PRODUCT IS PACKAGING WITH AND WITHOUT BUNDLING FDA UDI
- Model / Reference
- VAGINAL SUPPOSITORIES 2G FDA UDI
- Description
- THE PRODUCT IS PACKAGING WITH AND WITHOUT BUNDLING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08032595872436 FDA UDI
- 510(k) Number
- K153372 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- Vaginal mucosa protection dressing 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
Yes
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 mucosa protection dressing
Revaree by Farma Derma Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal mucosa protection dressing.
- AH! YES OB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES WB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES VM Vaginal Moisturizer — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES WB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES OB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES WB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES COCO Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES VM Vaginal Moisturizer — Bio-Tech Lubricants, Ltd. · Class II
Cleared under the same submission
K153372 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
- Farma Derma Srl
Sources (1)
- FDA UDI 69453e0d-0795-45ec-a6c1-493b21c260b8 34 fields · synced Jun 8, 2026