Duns Number:312293991
Device Description: This label goes directly on the centrifuge. The 3CP Centrifuge is a table-top centrifuge t This label goes directly on the centrifuge. The 3CP Centrifuge is a table-top centrifuge that creates the output (i.e., PRP).
Catalog Number
-
Brand Name
3CP™ Centrifuge
Version/Model Number
1
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
-
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
BK170002
Product Code
PMQ
Product Code Name
Peripheral Blood Processing Device For Wound Management
Public Device Record Key
8f0babc5-e2f6-4d21-91f2-2b25421350c9
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 19, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |