FDA UDI
In Commercial Distribution
🇺🇸 United States
Ibramed
DI: 07898966442957
·
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
- 07898966442957
- Version / Model
- Dermotonus Esthetic
- 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
- 2025-02-25
- Public Version
- 1
- Public Version Date
- 2025-03-05
- Public Version Status
- New
- Public Device Record Key
- 751a7ea2-f7a3-4d5c-b3df-4ce69ea3a640
Device Description
The DERMOTONUS ESTHETIC is a microcontrolled device that offers the following therapeutic modalities: MECHANICAL MASSAGE, VACUOTHERAPY, MICRODERMABRASION through DIAMOND PEELING, RADIOFREQUENCY, RADIOFREQUENCY ASSOCIATED WITH VACUUM AND TECARTHERAPY.
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36560 | Hand-held electric massager | An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898966442957 | GS1 |