Duns Number:079560357
Device Description: XCELL Platelet Concentrating System XC-PRP-60
Catalog Number
-
Brand Name
XCELL
Version/Model Number
XC-PRP-60
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
788e875f-09d2-4f32-9f49-75644fe8d38d
Public Version Date
March 11, 2021
Public Version Number
3
DI Record Publish Date
June 13, 2019
Package DI Number
B708XCPRP601
Quantity per Package
10
Contains DI Package
B708XCPRP600
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 |