FDA UDI
In Commercial Distribution
🇺🇸 United States
Vacusat power
DI: 04260277177461
·
Model: 00002318
·
Möller Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vacusat power
- Primary DI
- 04260277177461
- Version / Model
- 00002318
- 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
- 1bef586a-d716-4fba-bd23-5964f15d0f43
Device Description
Vacusat power is a powerful, low-noise extraction unit designed for continuous operation and suitable for high flow and vacuum rates. It extracts tumescence solution, body fats, fat cells (secretion, blood and serous liquids) and contained particles from natural and artificial body orifices and is designed for patient surgical vacuum extraction and liposuction. Vacusat power is applied in the clinical field or in medical practices by trained personnel. Vacusat power is neither suitable in the Home Care area for direct application by the patient nor suitable as drainage extractor. Do not use the extractor in cardiac surgery or in surgery on the central nervous system.
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
- No
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 | 04260277177461 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053451 | 000 |