FDA UDI
In Commercial Distribution
🇺🇸 United States
INDIBA DEEP CARE - PREMIUM
DI: 08434251000052
·
Model: IDC0076
·
INDIBA SA.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INDIBA DEEP CARE - PREMIUM
- Primary DI
- 08434251000052
- Version / Model
- IDC0076
- Catalog Number
- IDC0076
- Company Name
- INDIBA SA.
- Labeler DUNS
- 460060916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-22
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 0042acf6-6854-46b3-a597-941c35897a23
Device Description
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| PBX | Massager, vacuum, radio frequency induced heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45218 | Radio-frequency skin contouring system generator | A device that is part of a skin contouring system that generates radio-frequency (RF) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within body tissues to contour both the skin and underlying tissues through a process of skin regrowth and tightening and local fat cell alteration/destruction. The energy generated by this device is conducted through dedicated applicators that are moved across a patient's skin by professional personnel for treatment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08434251000052 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161458 | 000 |