FDA UDI
In Commercial Distribution
🇺🇸 United States
Ibramed
DI: 07898961579139
·
Model: Dermotonus Esthetic
·
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ibramed
- Primary DI
- 07898961579139
- Version / Model
- Dermotonus Esthetic
- Catalog Number
- 01006005
- Company Name
- Ibramed Industria Brasileira de Equipamentos Medicos Eir
- Labeler DUNS
- 903359565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-13
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1c2ed8b0-988e-4bc4-9df4-575cb7d11bff
Device Description
DERMOTONUS ESTHETIC is a device which allows treatments in the Health, Medical and Cosmetic areas, and which does not present systemic side-effects or causes dependency. DERMOTONUS ESTHETIC is a multifunctional equipment, used in the techniques of mechanical massage and vacuum therapy and in two modes of microdermabrasion: crystal peeling and diamond peeling.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFE | Brush, Dermabrasion, Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11177 | Skin abrasion unit | A mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898961579139 | GS1 |