Duns Number:320405061
Device Description: Vacusat power is a powerful, low-noise extraction unit designed for continuous operationan Vacusat power is a powerful, low-noise extraction unit designed for continuous operationand suitable for high flow and vacuum rates. It extracts tumescence solution, body fats, fatcells (secretion, blood and serous liquids) and contained particles from natural and artificialbody 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 patientnor suitable as drainage extractor. Do not use the extractor in cardiac surgery or insurgery on the central nervous system.
Catalog Number
-
Brand Name
Vacusat power
Version/Model Number
00002318
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053451
Product Code
QPB
Product Code Name
System, Suction, Lipoplasty For Removal
Public Device Record Key
1bef586a-d716-4fba-bd23-5964f15d0f43
Public Version Date
March 30, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |