Duns Number:079508934
Device Description: Puregraft 850 System (Made in USA)
Catalog Number
850/PURE
Brand Name
Puregraft
Version/Model Number
850
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
b7eab9a2-60a4-4fc7-b3a6-6463929a56a1
Public Version Date
December 06, 2019
Public Version Number
2
DI Record Publish Date
May 14, 2019
Package DI Number
10860407002222
Quantity per Package
5
Contains DI Package
00860407002225
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |