Duns Number:320405061
Catalog Number
-
Brand Name
Tubing for tumescent pump "Liposat"
Version/Model Number
00002251
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"
-
For Single-Use
Yes
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,K053451,K053451
Product Code
QPB
Product Code Name
System, Suction, Lipoplasty For Removal
Public Device Record Key
9e682d0e-16f9-48c6-aef5-2a7ffc1d48d7
Public Version Date
March 30, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
04260277175894
Quantity per Package
120
Contains DI Package
04260277175870
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |