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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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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.
4577OLY
In Commercial Distribution

  • M8494577OLY0 ()
  • M8494577OLY1 ()
4577OLY

  • Flexible polypectomy snare, single-use
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.
4575OLY
In Commercial Distribution

  • M8494575OLY0 ()
  • M8494575OLY1 ()
4575OLY

  • Flexible polypectomy snare, single-use
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.
4573OLY
In Commercial Distribution

  • M8494573OLY0 ()
  • M8494573OLY1 ()
4573OLY

  • Flexible polypectomy snare, single-use
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.
4573
In Commercial Distribution

  • M84945730 ()
  • M84945731 ()
4573

  • Flexible polypectomy snare, single-use
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.
4572
In Commercial Distribution

  • M84945720 ()
  • M84945721 ()
4572

  • Flexible polypectomy snare, single-use
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.
4571OLY
In Commercial Distribution

  • M8494571OLY0 ()
  • M8494571OLY1 ()
4571OLY

  • Flexible polypectomy snare, single-use
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.
4571
In Commercial Distribution

  • M84945710 ()
  • M84945711 ()
4571

  • Flexible polypectomy snare, single-use
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