Duns Number:260069352
Device Description: Cannula for fat injection or lipotransfer
Catalog Number
CF201590
Brand Name
DISPOSABLE FAT INJECTION CANNULA
Version/Model Number
2,11mm x 15 cm - 1-hole 90°
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
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
1c4f03bf-1ecf-405f-a568-a8f19d44889f
Public Version Date
December 13, 2019
Public Version Number
3
DI Record Publish Date
August 16, 2018
Package DI Number
03760037732158
Quantity per Package
10
Contains DI Package
03760037732165
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 |