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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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TSCD® II - 05020583620018

Sterile Tubing Welder
TERUMO BCT, INC.
62001
In Commercial Distribution

  • 05020583620018 ()


  • Package sealing unit

TSCD®-II - 05020583620001

Terumo Sterile Tubing Welder
TERUMO BCT, INC.
62000
In Commercial Distribution

  • 05020583620001 ()


  • Package sealing unit

Vista ® - 05020583252035

Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system

Vista® - 05020583252028

Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system

Vista ® - 05020583252011

Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


  • Blood bank information system

HAEMONETICS ACP 215 SYSTEM - 10812747015011

RBC DE-GLYCEROL./CELL WASH SET
HAEMONETICS CORPORATION
00235-00
In Commercial Distribution

  • 30812747015015 ()
  • 10812747015011 ()

  • Total Volume: 225 Milliliter
  • Total Volume: 5 Liter
  • Total Volume: 600 Milliliter


  • Blood cell freeze/thaw system set

HAEMONETICS ACP 215 SYSTEM - 10812747015004

RBC GLYCEROLIZATION SET
HAEMONETICS CORPORATION
00225-00
In Commercial Distribution

  • 30812747015008 ()
  • 10812747015004 ()


  • Blood cell freeze/thaw system set

FIBRINET - 10851802007080

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.
VERTICAL SPINE, LLC
510357
In Commercial Distribution

  • 30851802007084 ()
  • 10851802007080 ()

  • Total Volume: 50 Milliliter
510357

  • Haematological concentrate system preparation kit, platelet concentration

FIBRINET® - 10851802007073

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.
VERTICAL SPINE, LLC
510358
In Commercial Distribution

  • 30851802007077 ()
  • 10851802007073 ()

  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration

FIBRINET® - 10851802007066

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.
VERTICAL SPINE, LLC
510359
In Commercial Distribution

  • 30851802007060 ()
  • 10851802007066 ()

  • Total Volume: 45 Milliliter
510359

  • Haematological concentrate system preparation kit, platelet concentration
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