FDA UDI
In Commercial Distribution
🇺🇸 United States
Ibramed
DI: 07898961579122
·
Model: Dermotonus Slim
·
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
- 07898961579122
- Version / Model
- Dermotonus Slim
- Catalog Number
- 01006006
- 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
- 5
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- 21db4d54-9263-47e2-af66-5ff55c1c9b17
Device Description
DERMOTONUS SLIM 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 SLIM is a multifunctional equipment, used in the techniques of mechanical massage and vacuum therapy and the mode of microdermabrasion: 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 |
|---|---|---|---|---|
| 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 | 07898961579122 | GS1 |