Duns Number:076649467
Device Description: A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filtering, and transferring autologous fat tissue for reinjecting back into the same patient.
Catalog Number
-
Brand Name
Puregraft 850 System
Version/Model Number
850/PURE
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
K113255,K113255
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
b8b3a05a-bd3b-4fa9-a7d1-513f4a471744
Public Version Date
April 11, 2022
Public Version Number
1
DI Record Publish Date
April 01, 2022
Package DI Number
00850034511207
Quantity per Package
1
Contains DI Package
00850034511191
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |