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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
ROYAL BIOLOGICS INC.
PFRMK
In Commercial Distribution


  • Total Volume: 45 Milliliter
510359

  • Haematological concentrate system preparation kit, platelet concentration
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.
ROYAL BIOLOGICS INC.
PRFMK
In Commercial Distribution


  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration
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.
ROYAL BIOLOGICS INC.
PRFMK
In Commercial Distribution


  • Total Volume: 27 Milliliter
510357

  • Haematological concentrate system preparation kit, platelet concentration
Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
KEY SURGICAL, INC.
Cautery Tip Cleaner
In Commercial Distribution

  • 10849771052897 ()
  • 00849771052890 ()
  • 00849771030492 ()
TC200

  • Electrosurgical tip cleaning pad
Needleless Transfer Device
Shire Human Genetic Therapies, Inc.
3400691
In Commercial Distribution

3400691

  • Medication transfer set
Needleless Transfer Device
Shire Human Genetic Therapies, Inc.
5500460
In Commercial Distribution

5500460

  • Medication transfer set
Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler and 6 labels
KEY SURGICAL, INC.
Skin Marker
Not in Commercial Distribution

  • 10849771051012 ()
  • 00849771051015 ()
  • 00849771030485 ()
SM300

  • Skin marking pen, single-use
Vascular Loops, Sterile, Red, Mini, 2 per package
KEY SURGICAL, INC.
Vascular Loops
In Commercial Distribution

  • 10849771050541 ()
  • 00849771050544 ()
  • 00849771030836 ()

  • Diameter Cross Section 1.3mm x 0.9mm
  • Length: 18 Inch
VL201

  • Surgical vessel loop
Suture Booties, Pink (Large), Sterile, 5 pair per pad
KEY SURGICAL, INC.
Suture Booties
In Commercial Distribution

  • 10849771050503 ()
  • 00849771050506 ()
  • 00849771021056 ()

  • Lumen/Inner Diameter: 0.09 Inch
VB1120

  • Vascular booties
Suture Booties, White, Sterile, 5 pair per pad
KEY SURGICAL, INC.
Suture Booties
In Commercial Distribution

  • 10849771050473 ()
  • 00849771050476 ()
  • 00849771002666 ()
VB1105

  • Vascular booties
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