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 9 mL SELPHYL® System is available as a single pack (item number 420910) or as a multipack of 10individually packaged kits (item number 420910-10). The 9 mL SELPHYL® System contains 1 blood collection tubes with yellowstoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tubecontaining Calcium chloride solution with red stopper, 1 latex free disposable tourniquet, 1 BD Vacutainer® Luer-Lok™ accessdevice, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, and 1 BD Vacutainer®Blood transfer device.
Catalog Number
420910
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
3bd6eebf-85d8-4376-a4a5-149615f60a22
Public Version Date
September 30, 2022
Public Version Number
4
DI Record Publish Date
June 05, 2020
Package DI Number
30851802007091
Quantity per Package
10
Contains DI Package
10851802007097
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 |