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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
ARTERIOCYTE MEDICAL SYSTEMS, INC.
LTN105-O
In Commercial Distribution

  • M896LTN105O1 ()
  • M896LTN105O0 ()


  • Bone marrow biopsy needle, single-use
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.
COS320
Not in Commercial Distribution

  • M896COS3200 ()
  • M896COS3201 ()
COS320

  • 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.
COS310
Not in Commercial Distribution

  • M896COS3101 ()
  • M896COS3100 ()
COS310

  • Haematological concentrate system preparation kit, platelet concentration
Cell Point Disposable Kit with 45mm Lightning Needle
ARTERIOCYTE MEDICAL SYSTEMS, INC.
CLPT-PK-101-45
In Commercial Distribution

  • M896CLPTPK101451 ()
  • M896CLPTPK101450 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
CLPT-PK-101
In Commercial Distribution

  • M896CLPTPK1011 ()
  • M896CLPTPK1010 ()


  • 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.
BTI305
Not in Commercial Distribution

  • M896BTI3051 ()
  • M896BTI3050 ()
BTI305

  • 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.
BTI200
In Commercial Distribution

  • M896BTI2001 ()
  • M896BTI2000 ()
BTI200

  • Haematological concentrate system centrifuge
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.
BOS360
Not in Commercial Distribution

  • M896BOS3600 ()
  • M896BOS3601 ()
BOS360

  • 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.
BOS350
Not in Commercial Distribution

  • M896BOS3501 ()
  • M896BOS3500 ()
BOS350

  • 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.
BI0BAND
Not in Commercial Distribution

  • M896BI0BAND0 ()
  • M896BI0BAND1 ()
BI0BAND

  • Haematological concentrate system preparation kit, platelet concentration
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