Duns Number:260069352
Device Description: Disposable liposuction cannula
Catalog Number
LC 62802
Brand Name
Lipo-One®
Version/Model Number
6mm x 28 cm - 2-hole
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
f3089d00-5be5-4c3c-9608-f968a77b1096
Public Version Date
May 01, 2019
Public Version Number
3
DI Record Publish Date
August 13, 2018
Package DI Number
03760037734503
Quantity per Package
6
Contains DI Package
03760037734510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 92 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |