FDA UDI
In Commercial Distribution
🇺🇸 United States
Vibrasat power
DI: 04260277173890
·
Model: 00002246
·
Möller Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vibrasat power
- Primary DI
- 04260277173890
- Version / Model
- 00002246
- Company Name
- Möller Medical GmbH
- Labeler DUNS
- 320405061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2022-03-30
- Public Version Status
- Update
- Public Device Record Key
- b8eae22f-d537-43de-8191-d7119f6dcae8
Device Description
The vibrating drive system 'Vibrasat power' is used to oscillate liposuction cannulas during local tumescence anaesthesia. Use only the Möller Medical liposuction cannulas.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36894 | Liposuction system | An assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260277173890 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053451 | 000 |