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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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Autologous Platelet Separator - M896TRU2000

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

Autologous Platelet Separator - M896TRU1000

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

Magellan® RO-Max Convenience Kit - M896ROMAX0

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
RO-Max
Not in Commercial Distribution

  • M896ROMAX0 ()
  • M896ROMAX1 ()
RO-Max

  • Haematological concentrate system preparation kit, platelet concentration

Magellan® Complete One Source Kit - M896RO3100

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
RO-310
Not in Commercial Distribution

  • M896RO3101 ()
  • M896RO3100 ()
RO-310

  • Haematological concentrate system preparation kit, platelet concentration

Magellan® Complete Disposable kit - M896RO3000

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 - M896PRSAP0600

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 - M896PRCSAP1200

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 - M896PRCDIA1200

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 - M896PRCDIA0600

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

Autologous Serum Dispenser Kit - M896MSD4050

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.
MSD405
Not in Commercial Distribution

  • M896MSD4050 ()
  • M896MSD4051 ()
MSD405

  • Haematological concentrate system preparation kit, platelet concentration
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