Duns Number:079560357
Device Description: XCELL Platelet Concentrating System XC-PRP-60 Supplemental (accessory item)
Catalog Number
-
Brand Name
XCELL
Version/Model Number
XC-PRP-60 Supplemental
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
ORG
Product Code Name
Platelet And Plasma Separator For Bone Graft Handling
Public Device Record Key
15a186ec-c653-40f9-86ed-cda5ad824fe2
Public Version Date
March 11, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2019
Package DI Number
B708XCPRP60SUPP1
Quantity per Package
10
Contains DI Package
B708XCPRP60SUPP0
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |