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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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SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer.
SILFRADENT SRL
SURGYBONE na
In Commercial Distribution

  • 08056093310016 ()
  • 18056093310013 ()


  • Ultrasonic dental scaling/debridement system
The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15024-US
Not in Commercial Distribution

  • 03615220004171 ()
1001-15024-US

  • Electroencephalographic electrode cap, single-use
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-10006-US
Not in Commercial Distribution

  • 03615220003990 ()


  • Electroencephalographic ambulatory recorder
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
1001-01019-UN
In Commercial Distribution

  • 03615220003969 ()


  • Electroencephalographic electrode cap, single-use
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
1001-01018-UN
In Commercial Distribution

  • 03615220003952 ()


  • Electroencephalographic electrode cap, single-use
The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15024-UN
In Commercial Distribution

  • 03615220003846 ()
1001-15024-US

  • Electroencephalographic electrode cap, single-use
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
1001-01015-UN
In Commercial Distribution

  • 03615220003792 ()


  • Electroencephalographic electrode cap, single-use
GIRAFFE STAND-ALONE INFANT RESUSCITATION SYSTEM BAG AND MASK
Datex-Ohmeda, Inc.
Bag and Mask
In Commercial Distribution

  • 00840682100175 ()


  • Pulmonary resuscitator, pneumatic, reusable
The ESOTEST MULTI Monitor is a device for measuring the esophageal temperature through the ESOTEST MULTI Probe, which contains up to seven independent thermal sensors. The cable which connects the main body of the monitor to the probe is called ESOTEST MULTI Patient Cable. With ESOTEST MULTI Monitor it is possible to follow, in an immediate and precise way, the evolution of the temperature inside the esophagus. When an alarm is triggered, the system generates sound and visual effects aimed at getting the attention of the operator. The measured temperatures and the alarm conditions (if any) can be stored in the internal memory of the monitor and examined at a later time on the monitor itself or on an external personal computer (after exporting the corresponding data to an USB mass storage device). The ESOTEST MULTI MONITOR (30115 model number) is supplied togheter with the ESOTEST MULTI Patient Cable (F5417/US model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).
FIAB SPA
30115
In Commercial Distribution

  • 08054953344003 ()
30115

  • Oesophageal temperature monitor
The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.
GENERAL MEDICAL MERATE SPA
X-RAY R&F REMOTE SYSTEM OPERA SWING
In Commercial Distribution

  • 08054890480000 ()

  • Weight: 1120 Kilogram


  • Stationary general-purpose fluoroscopic x-ray system, digital
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