Duns Number:076649467
Device Description: A sterile, single use microsizing syringe system intended for the harvesting, concentratin A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous adipose tissue back to the same patient whenthe transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 micron filter for screening the tissue particle size to allow for easier injection through small, 18-21G injectors.
Catalog Number
-
Brand Name
Dermapose Refresh
Version/Model Number
REFRESH
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
e15bfc6b-9b88-4ff5-98a6-276e79e974a8
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 2022
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |