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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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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.
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
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
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
7202
Not in Commercial Distribution

  • M84972021 ()
  • M84972020 ()
7202

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
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
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