Duns Number:079560357
Device Description: XCELL Bone Marrow Aspirate Concentration System 60ml, convenience kit.
Catalog Number
-
Brand Name
XCELL
Version/Model Number
XC-BMC-SC-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
JQC
Product Code Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Public Device Record Key
9ea7a1eb-e560-4b4d-b854-6a69b6767a6c
Public Version Date
April 26, 2022
Public Version Number
1
DI Record Publish Date
April 18, 2022
Package DI Number
B708XCBMCSC601
Quantity per Package
6
Contains DI Package
B708XCBMCSC600
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 |