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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Tomography Only (SFOV)
Alliage S/A Indústrias Médico Odontológica
AXR120
In Commercial Distribution

  • 07899581335556 ()
16000003119

  • Cone beam computed tomography system, head/neck
Panoramic with Cephalostat (2 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581335549 ()
16000003049

  • Cone beam computed tomography system, head/neck
Panoramic with Cephalostat (1 sensor)
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581335532 ()
16000003048

  • Cone beam computed tomography system, head/neck
Panoramic Only
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581335525 ()
16000003047

  • Cone beam computed tomography system, head/neck
Zvu® HRAM Starter Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-200-17-KIT
In Commercial Distribution

  • 00816734022924 ()

  • Catheter Gauge: 17 French
HRAM-200-17-KIT

  • Manometric gastrointestinal motility analysis system
Zvu® HRAM Probe
DIVERSATEK HEALTHCARE, INC.
HRAM-200
In Commercial Distribution

  • 00816734022733 ()

  • Catheter Gauge: 17 French
HRAM-200

  • Manometric gastrointestinal motility analysis system
Zvu® HRiM Probe
DIVERSATEK HEALTHCARE, INC.
HRIM-201
In Commercial Distribution

  • 00816734022689 ()

  • Catheter Gauge: 12 French
HRIM-201

  • Manometric gastrointestinal motility analysis system
LessRay Extension, Table Array
Nuvasive, Inc.
8230042
In Commercial Distribution

  • 00887517976062 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Case, 12" C-Arm Collar
Nuvasive, Inc.
8230018
In Commercial Distribution

  • 00887517756770 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Articulating Arm, Camera
Nuvasive, Inc.
8230017
In Commercial Distribution

  • 00887517756763 ()


  • Diagnostic x-ray digital imaging system workstation
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