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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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The Hobbs Cytology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.
HOBBS MEDICAL, INC.
4102
In Commercial Distribution

  • M84941020 ()
  • M84941022 ()
4102

  • Flexible endoscopic cytology brush, single-use
No Description
HOBBS MEDICAL, INC.
4101
In Commercial Distribution

  • M84941012 ()
  • M84941010 ()
4101

  • Saccamanno solution IVD
A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.
HOBBS MEDICAL, INC.
2190
In Commercial Distribution

  • M84921901 ()
  • M84921900 ()
2190

  • Endoscopic spray catheter, single-use
A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
HOBBS MEDICAL, INC.
2181
In Commercial Distribution

  • M84921811 ()
  • M84921810 ()
2181

  • Tracheobronchial suction/insufflation catheter, single-lumen
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.
MAR01-BTI-80-O
Not in Commercial Distribution

  • M896MAR01BTI80O0 ()
  • M896MAR01BTI80O1 ()
MAR01-BTI-80-O

  • 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.
MAR01-BTI-80
Not in Commercial Distribution

  • M896MAR01BTI800 ()
  • M896MAR01BTI801 ()
MAR01-BTI-80

  • 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.
MAR01-BTI-45-O
Not in Commercial Distribution

  • M896MAR01BTI45O0 ()
  • M896MAR01BTI45O1 ()
MAR01-BTI-45-O

  • 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.
MAR01-BTI-45
Not in Commercial Distribution

  • M896MAR01BTI450 ()
  • M896MAR01BTI451 ()
MAR01-BTI-45

  • 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.
MAR01-ATS
In Commercial Distribution

  • M896MAR01ATS0 ()
  • M896MAR01ATS1 ()
MAR01-ATS

  • 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.
MAR01-AO
Not in Commercial Distribution

  • M896MAR01AO0 ()
  • M896MAR01AO1 ()
MAR01-AO

  • Haematological concentrate system preparation kit, platelet concentration
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