Duns Number:260069352
Device Description: Flexible micro cannulas to inject a filler (synthetic or autologous fat) under the skin.
Catalog Number
MI18110KR
Brand Name
DISPOSABLE MICRO CANNULA FOR FILLER INJECTION
Version/Model Number
18gauge x 11 cm - 1-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
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
c63ca9b3-fb45-42b6-8828-60dd8b003fa4
Public Version Date
December 12, 2019
Public Version Number
2
DI Record Publish Date
May 09, 2019
Package DI Number
03760037734756
Quantity per Package
20
Contains DI Package
03760037734763
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 |