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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
Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor.
LUCERNO DYNAMICS, LLC
091220-018
In Commercial Distribution

  • 00850014578145 ()
  • 00850014578138 ()
091220-018

  • Hypoallergenic skin adhesive tape
No Description
LUCERNO DYNAMICS, LLC
G
In Commercial Distribution

  • 00850014578121 ()
401874-100-2

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
G
In Commercial Distribution

  • 00850014578114 ()
401874-100-1

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578251 ()
  • 00850014578107 ()
401874-285

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
2
In Commercial Distribution

  • 00850014578268 ()
  • 00850014578091 ()
401874-200

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578244 ()
  • 00850014578084 ()
401874-220-8

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578237 ()
  • 00850014578077 ()
401874-220-7

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578220 ()
  • 00850014578060 ()
401874-220-6

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578213 ()
  • 00850014578053 ()
401874-220-5

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578206 ()
  • 00850014578046 ()
401874-220-4

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578190 ()
  • 00850014578039 ()
401874-220-3

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578183 ()
  • 00850014578022 ()
401874-220-2

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578176 ()
  • 00850014578015 ()
401874-220-1

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578169 ()
  • 00850014578008 ()
401874-230

  • Scintillation-counter radiation survey meter
Lumbar Interbody Fusion System (OLLIF) Tray - Basket Without Logo
ADVANCED RESEARCH MEDICAL LLC
01-B2
In Commercial Distribution

  • 00850014575823 ()
01-B2

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Tray - Basket With Logo
ADVANCED RESEARCH MEDICAL LLC
01-B1
In Commercial Distribution

  • 00850014575816 ()
01-B1

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Tray - Bottom Platform
ADVANCED RESEARCH MEDICAL LLC
01-P3
In Commercial Distribution

  • 00850014575809 ()
01-P3

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Tray - Middle Platform
ADVANCED RESEARCH MEDICAL LLC
01-P2
In Commercial Distribution

  • 00850014575793 ()
01-P2

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Tray - Top Platform
ADVANCED RESEARCH MEDICAL LLC
01-P1
In Commercial Distribution

  • 00850014575786 ()
01-P1

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Guide Wire - 1.4 mm X 18 in [Unthreaded]
ADVANCED RESEARCH MEDICAL LLC
01-9080-18U
In Commercial Distribution

  • 10850014575776 ()
  • 00850014575779 ()
  • 20850014575773 ()
  • 30850014575770 ()

  • Guidewire Diameter: 1.4 Millimeter
  • Length: 18 Inch
01-9080-18U

  • Spinal guidewire
Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Light Guide Alignment Sleeve
ADVANCED RESEARCH MEDICAL LLC
01-14-6
In Commercial Distribution

  • 00850014575762 ()
01-14-6

  • Orthopaedic implantation sleeve, reusable
Lumbar Interbody Fusion System (OLLIF) Flexible Curette Caddy and Lid
ADVANCED RESEARCH MEDICAL LLC
01-C4
In Commercial Distribution

  • 00850014575755 ()
01-C4

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) 33 mm Implant Caddy and Lid
ADVANCED RESEARCH MEDICAL LLC
01-C3
In Commercial Distribution

  • 00850014575731 ()
01-C3

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) 30 mm Implant Caddy and Lid
ADVANCED RESEARCH MEDICAL LLC
01-C2
In Commercial Distribution

  • 00850014575724 ()
01-C2

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) 27 mm Implant Caddy and Lid
ADVANCED RESEARCH MEDICAL LLC
01-C1
In Commercial Distribution

  • 00850014575717 ()
01-C1

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Case Assembly without Logo
ADVANCED RESEARCH MEDICAL LLC
01-T2
In Commercial Distribution

  • 00850014575700 ()
01-T2

  • Instrument tray, reusable
Lumbar Interbody Fusion System (OLLIF) Case Assembly with Logo
ADVANCED RESEARCH MEDICAL LLC
01-T1
In Commercial Distribution

  • 00850014575694 ()
01-T1

  • Instrument tray, reusable
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