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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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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
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
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.
4108
In Commercial Distribution

  • M84941080 ()
  • M84941082 ()
4108

  • Flexible endoscopic cytology brush, single-use
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.
2191
In Commercial Distribution

  • M84921911 ()
  • M84921910 ()
2191

  • 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.
2182
In Commercial Distribution

  • M84981821 ()
  • M84921820 ()
2182

  • Irrigation catheter, single-lumen
Immunoassay for the detection of buprenorphine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7106
In Commercial Distribution

  • M90107RD71061 ()
  • M90107RD71060 ()

  • Length: 75 Millimeter
07RD7106

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of buprenorphine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7105
In Commercial Distribution

  • M90107RD71051 ()
  • M90107RD71050 ()

  • Length: 75 Millimeter
07RD7105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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