Duns Number:320405061
Device Description: The "Liposat power" tumescence pump serves to guide a sodium chloride solution into human The "Liposat power" tumescence pump serves to guide a sodium chloride solution into human tissue in a sterile manner through a tube system using insertion needles. The "Liposat power" tumescence pump should be used only with the tube set from Möller Medical, "Liposat tube set for tumescence infiltration" (REF: 00002251).
Catalog Number
-
Brand Name
Liposat power infiltration pump
Version/Model Number
00002274
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
5ac12de1-4548-4f2d-9792-34cf4e374ad2
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 |