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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 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
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15023-UN
Not in Commercial Distribution

  • 03615220003679 ()


  • Electroencephalographic ambulatory recorder
No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15022-UN
Not in Commercial Distribution

  • 03615220003662 ()


  • 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
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