Duns Number:079560357
Device Description: XCELL Platelet Concentrating System XC-RV-60 RegenVET (Veterinary Applications) Blood Draw XCELL Platelet Concentrating System XC-RV-60 RegenVET (Veterinary Applications) Blood Draw Kit
Catalog Number
-
Brand Name
XCELL
Version/Model Number
XC-RV-BDK1
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
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
06b5fe00-635a-46dd-a3e6-aecdd702818d
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 2021
Package DI Number
B708XCRVBDK11
Quantity per Package
10
Contains DI Package
B708XCRVBDK10
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 |