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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.
LTN45-O
In Commercial Distribution

  • M896LTN45O1 ()
  • M896LTN45O0 ()


  • Bone marrow biopsy needle, single-use
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
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
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.
AMS350
In Commercial Distribution

  • M896AMS3500 ()
  • M896AMS3501 ()
AMS350

  • 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.
AMS310
In Commercial Distribution

  • M896AMS3101 ()
  • M896AMS3100 ()
AMS310

  • 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.
AMS300
In Commercial Distribution

  • M896AMS3001 ()
  • M896AMS3000 ()
AMS300

  • Haematological concentrate system preparation kit, platelet concentration
An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).
HOBBS MEDICAL, INC.
G1120040
In Commercial Distribution

  • M849G11200400 ()
  • M849G11200401 ()
4581-U

  • Inert gas-enhanced endoscopic electrosurgical electrode, reusable
No Description
HOBBS MEDICAL, INC.
4650
In Commercial Distribution

  • M84946501 ()
  • M84946500 ()
4650

  • Endoscopic procedure air/water valve, single-use
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