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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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Zeto ONE Display Unit - B675ONEDU0

The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Display Unit is the parent device of the Flexset System, intended to: - power the Zeto ONE Head Unit. - aquire the Zeto ONE Head Unit's signals - transmit the obtained data to the Zeto Cloud Platform - display the currently detected EEG signals - control the recording process
ZETO INC
ZP-140-11001
In Commercial Distribution

  • B675ONEDU0 ()


  • Electroencephalograph

Signature ONE Software Package - 00889024647046

v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647046 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024647039

v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647039 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024585393

v. 1.0
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024585393 ()
302.4018

  • Radiology DICOM image processing application software

Myotrode One without Gel - D79240702

Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.
MYOTRONICS NOROMED, INC
4070
In Commercial Distribution

  • D79240702 ()


  • Transcutaneous electrical stimulation electrode, single-use

Myotrode One With Gel - D79240602

Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
MYOTRONICS NOROMED, INC
4060
In Commercial Distribution

  • D79240602 ()


  • Transcutaneous electrical stimulation electrode, single-use

KOHNO ONE IMPLANT ZIRTI - D7701304953

KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.13 MM
SWEDEN & MARTINA SPA
KS-ZT-500-130
In Commercial Distribution

  • D7701304953 ()
KS-ZT-500-130

  • Screw endosteal dental implant, two-piece

KOHNO ONE IMPLANT ZIRTI - D7701304943

KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.11.5 MM
SWEDEN & MARTINA SPA
KS-ZT-500-115
In Commercial Distribution

  • D7701304943 ()
KS-ZT-500-115

  • Screw endosteal dental implant, two-piece

KOHNO ONE IMPLANT ZIRTI - D7701304933

KOHNO ONE IMPLANT ZIRTI ZT D.5.00 H.10 MM
SWEDEN & MARTINA SPA
KS-ZT-500-100
In Commercial Distribution

  • D7701304933 ()
KS-ZT-500-100

  • Screw endosteal dental implant, two-piece

KOHNO ONE IMPLANT ZIRTI - D7701304923

KOHNO ONE IMPLANT ZIRTI ZT D.4.25 H.18 MM
SWEDEN & MARTINA SPA
KS-ZT-425-180
In Commercial Distribution

  • D7701304923 ()
KS-ZT-425-180

  • Screw endosteal dental implant, two-piece
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