Factor Medical, Inc.

Address:300 Baker avenue,Concord,MA,01742,US

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- Catalog Number : 420910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 9 mL SELPHYL® System is available as a single pack (item number 420910) or as a multipack of 10 individually packaged kits (item number 420910-10).The 9 mL SELPHYL® System contains 1 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube 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 BD Vacutainer® Blood transfer device.

Device Class : 2

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 430910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 9 mL SELPHYL® System is available as a single pack (item number 430910) or as a multipack of 10 each individually packaged kits (item number 430910-10).The 9 mL SELPHYL® System contains a blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, a 10 mL PRFM vial with closure containing Calcium chloride solution, 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 BD Vacutainer® Blood transfer device.

Device Class : 2

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 440910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 18 mL SELPHYL® System is available as a single pack (item number 440910) or as a multipack of 10 each individually packaged kits (item number 440910-10).The 18 mL SELPHYL® System contains 2 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 2 PRFM tubes 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 BD Vacutainer® Blood transfer device.

Device Class :

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 450910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 18 mL SELPHYL® System is available as a single pack (item number 450910) or as a multipack of 10 each individually packaged kits (item number 450910-10).The 18 mL SELPHYL® System contains 2 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, a 20 mL PRFM vialwith closure containing calcium chloride solution, 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 BD Vacutainer® Blood transfer device.

Device Class : 2

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 480910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and preserve platelets. The 36 mL SELPHYL® System is available as a single pack (item number 480910) or as a multipack of 10 each individually packaged kits (item number 480910-10).The 36 mL SELPHYL® System contains 4 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 4 PRFM tubes containing calcium chloride solution with red stoppers, 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 BD Vacutainer® Blood transfer device.

Device Class : 2

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 420910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous 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.

Device Class : 2

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 440910

Device Description : The SELPHYL® System is designed for the safe and rapid preparation of autologous 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.

Device Class : 2

Duns Number: 117697569

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1