Duns Number:117697569
Device Description: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-
Catalog Number
440910
Brand Name
SELPHYL®
Version/Model Number
PRFM
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
BK170096,BK170096,BK170096
Product Code
ORG
Product Code Name
Platelet And Plasma Separator For Bone Graft Handling
Public Device Record Key
e9134f6d-77f2-4648-ab4e-4ce042b9bd3e
Public Version Date
September 30, 2022
Public Version Number
3
DI Record Publish Date
June 05, 2020
Package DI Number
30851802007107
Quantity per Package
10
Contains DI Package
10851802007103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |