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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.
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
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.
BI0BAND
Not in Commercial Distribution

  • M896BI0BAND0 ()
  • M896BI0BAND1 ()
BI0BAND

  • 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.
AMS312
In Commercial Distribution

  • M896AMS3120 ()
  • M896AMS3121 ()
AMS312

  • 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.
AMS305
In Commercial Distribution

  • M896AMS3051 ()
  • M896AMS3050 ()
AMS305

  • 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.
AMS100
In Commercial Distribution

  • M896AMS1001 ()
  • M896AMS1000 ()
AMS100

  • 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.
40-K10-0001
In Commercial Distribution

  • M89640K1000010 ()
  • M89640K1000011 ()
40-K10-0001

  • Haematological concentrate system preparation kit, platelet concentration
A flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.
HOBBS MEDICAL, INC.
5030S
In Commercial Distribution

  • M8495030S0 ()
  • M8495030S1 ()
5030S

  • Flexible endoscopic tissue manipulation forceps, single-use
No Description
HOBBS MEDICAL, INC.
4650
In Commercial Distribution

  • M84946501 ()
  • M84946500 ()
4650

  • Endoscopic procedure air/water valve, single-use
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