Duns Number:117697569
Device Description: The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet- The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a smallsample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP isconverted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect andpreserve platelets. The 18 mL SELPHYL® System is available as a single pack (item number 440910) or as a multipack of 10each individually packaged kits (item number 440910-10). The 18 mL SELPHYL® System contains 2 blood collection tubes withyellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 2 PRFMtubes containing calcium chloride solution with red stopper, 1 latex free disposable tourniquet, 1 BD Vacutainer® Luer-Lok™access device, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, and 1 BDVacutainer® Blood transfer device.
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 |