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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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No Description
ALLIANCE PARTNERS LLC
CYCP-60-02
In Commercial Distribution

  • M686CYCP60020 ()
CYCP-60-02

  • Haematological concentrate system
No Description
ALLIANCE PARTNERS LLC
CYC-60-02
In Commercial Distribution

  • M686CYC60020 ()
CYC-60-02

  • Haematological concentrate system
No Description
ALLIANCE PARTNERS LLC
CYC-120-02
In Commercial Distribution

  • M686CYC120020 ()
CYC-120-02

  • Haematological concentrate system
S-Monovette® 8.8 ml ACD-A
Sarstedt Aktiengesellschaft & Co.KG
01.1624.001
In Commercial Distribution

  • 04038917228299 ()
  • 04038917228305 ()
  • 04038917228312 ()
01.1624.001

  • Non-evacuated blood collection tube IVD, anticoagulant
No Description
Regenlab USA LLC
RK-THT-3
Not in Commercial Distribution

  • 08500331310073 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Regenlab USA LLC
RK-BCT-3
Not in Commercial Distribution

  • 08500331310066 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Regenlab USA LLC
RK-BCT-1
Not in Commercial Distribution

  • 08500331310042 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Regenlab USA LLC
A-CP-3
Not in Commercial Distribution

  • 08500331310011 ()


  • Haematological concentrate system preparation kit, platelet concentration
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.
Factor Medical, Inc.
PRFM
In Commercial Distribution

  • 30851802007107 ()
  • 10851802007103 ()
  • 10851802007035 ()

  • Total Volume: 18 Milliliter
440910

  • Haematological concentrate system preparation kit, platelet concentration
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.
Factor Medical, Inc.
PRFM
In Commercial Distribution

  • 30851802007091 ()
  • 10851802007097 ()
  • 10851802007004 ()

  • Total Volume: 9 Milliliter
420910

  • Haematological concentrate system preparation kit, platelet concentration
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