FDA UDI
In Commercial Distribution
🇺🇸 United States
Liposat Pro plus
DI: 04260632792308
·
Model: 00003974
·
Möller Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Liposat Pro plus
- Primary DI
- 04260632792308
- Version / Model
- 00003974
- Company Name
- Möller Medical GmbH
- Labeler DUNS
- 320405061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-21
- Public Version
- 1
- Public Version Date
- 2020-01-29
- Public Version Status
- New
- Public Device Record Key
- 8b3fb72a-d1e0-43e1-8885-980ee9fdc4b7
Device Description
The "Liposat Pro plus" is a pump that is used in the field of aesthetic body contouring. The "Liposat Pro plus" is used to promote aqueous solutions for the production of tumescence local anesthesia as well as body-own, subcutaneous tissue and its components in the body. The pump "Liposat Pro plus" may only be used with the tube set "TLA Tubing Liposat Pro plus" and "Fat Tubing Liposat Pro plus" of the the Möller Medical GmbH.
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 |
|---|---|---|---|---|
| MUU | System, Suction, Lipoplasty | 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 | 04260632792308 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053451 | 000 |