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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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EnsoSleep - 00864458000476

Automated sleep study scoring and report generation by EnsoData
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000476 ()


  • Sleep disorder interpretive software, professional-only

EnsoSleep - 00864458000414

No Description
ENSODATA, INC.
7.0
In Commercial Distribution

  • 00864458000414 ()


  • Sleep disorder interpretive software, professional-only

NA - 00841983103742

POUCH, INPUT BOX HOLDER
NIHON KOHDEN AMERICA, INC.
A/POUCHTRIFOLD
In Commercial Distribution

  • 00841983103742 ()
A/POUCHTRIFOLD

  • Electroencephalograph

NA - 00841983103735

POUCH, MINI INPUT BOX
NIHON KOHDEN AMERICA, INC.
A/POUCH-JE922
In Commercial Distribution

  • 00841983103735 ()
A/POUCH-JE922

  • Electroencephalograph

NA - 00841983102271

Mini electrode junction box (10-20 type, 64)
NIHON KOHDEN AMERICA, INC.
JE-208A
In Commercial Distribution

  • 00841983102271 ()
JE-208A

  • Electroencephalograph

NA - 00841983102264

Electrode junction box (64)
NIHON KOHDEN AMERICA, INC.
JE-207A
In Commercial Distribution

  • 00841983102264 ()
JE-207A

  • Electroencephalograph

NA - 00841983103308

AMPLIFIER, 192 CHANNEL
NIHON KOHDEN AMERICA, INC.
JE-212A
In Commercial Distribution

  • 00841983103308 ()
JE-212A

  • Neurophysiologic monitoring system

NA - 00841983103292

INPUT BOX, EEG 128 CHANNEL, for EEG1200
NIHON KOHDEN AMERICA, INC.
JE-209A
In Commercial Distribution

  • 00841983103292 ()
JE-209A

  • Electroencephalograph

NA - 00841983103155

STIMULATION SWITCH BOX, 192 CHANNEL
NIHON KOHDEN AMERICA, INC.
AAA-16060
In Commercial Distribution

  • 00841983103155 ()
AAA-16060

  • Neurophysiologic monitoring system

NA - 00841983102493

Mini electrode junction box, JE-921A
NIHON KOHDEN AMERICA, INC.
JE-922A
In Commercial Distribution

  • 00841983102493 ()
JE-922A

  • Electroencephalograph
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