AccessGUDID - DEVICE: Vacusat power (04260277173906)

GUDID

Device Identifier (DI) Information

Brand Name: Vacusat power
Version or Model: 00002252
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Möller Medical GmbH

Primary DI Number: 04260277173906
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320405061 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QPB	System, Suction, Lipoplasty For Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053451	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 610b770c-e80f-447d-a693-eb5fe4f8f793
Public Version Date: March 30, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016