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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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Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU310
Not in Commercial Distribution

  • M896TRU3100 ()
  • M896TRU3101 ()
TRU310

  • Haematological concentrate system preparation kit, platelet concentration
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU300-O
In Commercial Distribution

  • M896TRU300O0 ()
  • M896TRU300O1 ()
TRU300-O

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU300-JPN
In Commercial Distribution

  • M896TRU300JPN1 ()
  • M896TRU300JPN0 ()


  • Haematological concentrate system preparation kit, platelet concentration
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU300
In Commercial Distribution

  • M896TRU3000 ()
  • M896TRU3001 ()
TRU300

  • Haematological concentrate system preparation kit, platelet concentration
MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU200
In Commercial Distribution

  • M896TRU2001 ()
  • M896TRU2000 ()
TRU200

  • Haematological concentrate system centrifuge
MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU100
In Commercial Distribution

  • M896TRU1001 ()
  • M896TRU1000 ()
TRU100

  • Haematological concentrate system centrifuge
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
RO-Max
Not in Commercial Distribution

  • M896ROMAX0 ()
  • M896ROMAX1 ()
RO-Max

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
RO-310
Not in Commercial Distribution

  • M896RO3101 ()
  • M896RO3100 ()
RO-310

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
RO-300
Not in Commercial Distribution

  • M896RO3001 ()
  • M896RO3000 ()
RO-300

  • Haematological concentrate system preparation kit, platelet concentration
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
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