ubsaesthetics.com
ubsmed.comSelphyl PRP Tube - Blood separation tube for PRP
2024-08-03
FACTOR MEDICAL Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012453008 | 3012453008 | FACTOR MEDICAL Inc. | 1 | N | 2026-01-01 | 300 Baker avenue Suite 300 Concord MA US 01742 |
| 3033334123 | 3033334123 | FACTOR MEDICAL, INC | 1 | N | 2026-01-01 | 41 University Dr Ste 400 Newtown PA US 18940 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851802007113 | Selphyl PRP Tube - Blood separation tube for PRP | 6103171670 | jfaust@ubsmed.com |
| 00851802007120 | Selphyl PRFM Tube - Blood separation tube for PRFM | 6103171670 | jfaust@ubsmed.com |
| 10851802007004 | SELPHYL® - "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." | 6103171670 | jfaust@ubsaesthetics.com |
| 10851802007028 | SELPHYL® - "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." | 6103171670 | jfaust@ubsaesthetics.com |
| 10851802007042 | SELPHYL® - "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." | 6103171670 | jfaust@ubsaesthetics.com |
| 10851802007059 | SELPHYL® - "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." | 6103171670 | jfaust@ubsaesthetics.com |
| 10851802007097 | SELPHYL® - "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." | 6103171670 | jfaust@ubsmed.com |
| 10851802007103 | SELPHYL® - "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." | 6103171670 | jfaust@ubsmed.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 192999 | 1455616325 | BK170096 |
| 332957 | 1211616117 |
GUDID#
Selphyl PRFM Tube - Blood separation tube for PRFM
2024-08-03
SELPHYL® - "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."
2016-09-23
SELPHYL® - "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."
2016-09-23
SELPHYL® - "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."
2016-09-23
SELPHYL® - "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."
2016-09-23
SELPHYL® - "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."
2020-06-05
SELPHYL® - "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."
2020-06-05
SELPHYL® - "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."
2016-09-23
SELPHYL® - 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.
2020-06-05
SELPHYL® - 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.
2020-06-05
SELPHYL® - 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.
2016-09-23
SELPHYL® - 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.
2016-09-23
SELPHYL® - 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.
2016-09-23
SELPHYL® - 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.
2016-09-23