FDA UDI
In Commercial Distribution
🇺🇸 United States
REVAREE PLUS
DI: 08032595872078
·
Model: VAGINAL SUPPOSITORIES 2G
·
FARMA DERMA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- REVAREE PLUS
- Primary DI
- 08032595872078
- Version / Model
- VAGINAL SUPPOSITORIES 2G
- Company Name
- FARMA DERMA SRL
- Labeler DUNS
- 541677746
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-03-27
- Public Version
- 1
- Public Version Date
- 2024-04-04
- Public Version Status
- New
- Public Device Record Key
- 006eeb1b-fe10-4d7b-b9a2-db03a2349df2
Device Characteristics
- Single Use
- Yes
- 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
- No
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 |
|---|---|---|---|---|
| 47899 | Vaginal mucosa protection dressing | A substance (e.g., gel, cream, suppository) containing various compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to be applied in and around the vagina to: 1) promote and/or expedite the healing, re-epithelialization, and/or soothing/lubrication of dry, injured, atrophic, or irritated vaginal mucosa; and/or 2) function as barrier to prevent adherence of pathogenic microorganisms (especially mycotic) to the vulvo-vaginal mucosa. It is intended for use in the home or healthcare facility to manage procedure-related injury (e.g., childbirth, surgery, radiotherapy), menopause, or various pathologies (e.g., vulvovaginitis). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08032595871958 | GS1 | ||||
| Primary | 08032595872078 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213220 | 000 |