Duns Number:076649467
Device Description: A pre-assembled, sterile, single use system intended to assist the harvesting of autologou A pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat grafts from a patient for aesthetic body contouring. It creates a guidedincision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest.
Catalog Number
-
Brand Name
Dermapose Access
Version/Model Number
ACCESS
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
QPB
Product Code Name
System, Suction, Lipoplasty For Removal
Public Device Record Key
8852d940-0bfa-48e7-a07f-9c8acfdb71d9
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 |