ROYAL BIOLOGICS INC.

Address:401 Hackensack Ave,Hackensack,NJ,07601,US

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- Catalog Number : MXPRP-1

Device Description : The Royal MAXX™ PRP concentration system is designed to be used for the safe and The Royal MAXX™ PRP concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and phlebotomy supplies.

Device Class : 2

Duns Number: 080562141

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : MXCB-1

Device Description : The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and B The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and BMC concentration systems. The kit contains 2 reuseable Royal MAXX Counterbalances and 2 reuseable Turn keys .

Device Class : 2

Duns Number: 080562141

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : MXBMC-60

Device Description : The Royal MAXX™ BMC concentration system is designed to be used for the safe and The Royal MAXX™ BMC concentration system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of a mixture of peripheral blood and bone marrow aspirate at the patient’s point of care for mixing with autograft and/or allograft bone to improve handling characteristics. The system consists of a kit of consumables including a concentration device, syringes, blunt needle, alcohol wipes, ACD-A anticoagulant, and bone marrow aspiration supplies.

Device Class :

Duns Number: 080562141

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 510357

Device Description : The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FI The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The FIBRINET® Accessory Kit is available as a single pack (item number 510357) or as a multipack of 5 individually packaged kits (item number 510357-5). The FIBRINET® Accessory Kit contains 1 disposable centrifuge carrier with insert and cap and 1 - 50 mL Falcon® tube.

Device Class : 2

Duns Number: 080562141

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 510358

Device Description : The FIBRINET® System is designed to be used for the safe and rapid preparation o The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 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, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.

Device Class : 2

Duns Number: 080562141

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

- Catalog Number : 510359

Device Description : The FIBRINET® System is designed to be used for the safe and rapid preparation o The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 45 mL FIBRINET® System is available as a single pack (item number 510359) or as a multipack of 5 individually packaged kits (item number 510359-5). The 45 mL FIBRINET® System contains 5 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, two 30 mL membrane vials with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.

Device Class : 2

Duns Number: 080562141

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1