Duns Number:080357711
Device Description: The ProGen PC design concept is predicated on providing an easy to use device for platelet The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
Catalog Number
BELL-82380-A
Brand Name
ProGen PC Kit
Version/Model Number
BELL-82380-A
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
BK130079,BK130079
Product Code
ORG
Product Code Name
Platelet And Plasma Separator For Bone Graft Handling
Public Device Record Key
7f0c59c8-cd07-4cea-afd5-d19df00403d2
Public Version Date
July 23, 2020
Public Version Number
5
DI Record Publish Date
December 21, 2016
Package DI Number
10861122000319
Quantity per Package
10
Contains DI Package
00861122000312
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |