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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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Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution

  • 10852714003108 ()


  • Wound dressing kit, medicated
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
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
DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures. For use with DG Gel 8 technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
4 x 6 ml
In Commercial Distribution

  • 07640137340605 ()
213285

  • Multiple immunohaematology test IVD, control
Precise Sapphire - 60 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-060
In Commercial Distribution

  • M896PRCSAP0601 ()
  • M896PRSAP0600 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Sapphire - 120 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-120
In Commercial Distribution

  • M896PRCSAP1201 ()
  • M896PRCSAP1200 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Diamond - 120 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-120
In Commercial Distribution

  • M896PRCDIA1201 ()
  • M896PRCDIA1200 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Diamond - 60 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-060
In Commercial Distribution

  • M896PRCDIA0600 ()
  • M896PRCDIA0601 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-056
In Commercial Distribution

  • M896AMS500350560 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-053
In Commercial Distribution

  • M896AMS500350530 ()


  • Haematological concentrate system preparation kit, platelet concentration
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