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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 device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism which is controlled by a foot-pedal.
GENERAL MEDICAL MERATE SPA
STRETCHER
In Commercial Distribution

  • 08054890480031 ()

  • Width: 65 Centimeter
  • Length: 210 Centimeter


  • Radiographic stretcher
ESOTEST Monitor is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temperature threshold alarm value between 36°C and 41°C. ESOTEST Monitor is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ESOTEST Probe. Using this device it is possible to follow, in immediate and precise way, the rise of the temperature inside the esophagous. The incorporated alarm system allows to the operator to set an adequate threshold temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm, the temperature and alarm signals can be sent to an external display and recording system through output signal connector. ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: monitor (30112 model numeber ), interconnect cable(F5406/ULTRA model number) and probe (26155S/US model number).
FIAB SPA
30112
In Commercial Distribution

  • 08054242446364 ()
30112

  • Oesophageal temperature monitor
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15023-UN
Not in Commercial Distribution

  • 03615220003679 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15021-UN
Not in Commercial Distribution

  • 03615220003655 ()


  • Electroencephalographic ambulatory recorder
Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15020-UN
In Commercial Distribution

  • 03615220003624 ()


  • Electroencephalographic electrode cap, reusable
The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01014-UN
In Commercial Distribution

  • 03615220003617 ()


  • Electroencephalographic electrode cap, single-use
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15022-UN
Not in Commercial Distribution

  • 03615220003662 ()


  • Electroencephalographic ambulatory recorder
ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temperature threshold alarm value between 36°C and 41°C. ST-MONITOR is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ST-PROBE. Using this device it is possible to follow, in immediate and precise way, the rise of the temperature inside the esophagous. The incorporated alarm system allows to the operator to set an adequate threshold temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm, the temperature and alarm signals can be sent to an external display and recording system through output signal connector. Sensitherm Multi System is intended for continue esophageal temperature monitoring and it consists of 3 components: ST-MONITOR, Patient Cable (ST-PTCBL model number) and Probe (ST-PROBE model number).
FIAB SPA
ST-MONITOR
In Commercial Distribution

  • 08058480754021 ()
ST-MONITOR

  • Oesophageal temperature monitor
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5551
In Commercial Distribution

  • MCS55511 ()
  • EAMIMCS55510 ()
MCS5551

  • Tissue extraction bag
More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5531
In Commercial Distribution

  • EAMIMCS55311 ()
  • EAMIMCS55310 ()
MCS5531

  • Tissue extraction bag
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