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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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SHINING3D® - 06970163082707

No Description
Shining 3D Tech Co., Ltd.
Atip 3iWS
In Commercial Distribution

  • 06970163082707 ()


  • Dental milling system, CAD/CAM, chairside

SHINING3D® - 06970163082684

No Description
Shining 3D Tech Co., Ltd.
Atip 3iWL
In Commercial Distribution

  • 06970163082684 ()


  • Dental milling system, CAD/CAM, chairside

SHINING 3D® - 06970163080390

The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan L
In Commercial Distribution

  • 06970163080390 ()


  • Dental milling system, CAD/CAM, chairside

Zvu® - 00816734022733

Zvu® HRAM Probe
DIVERSATEK HEALTHCARE, INC.
HRAM-200
In Commercial Distribution

  • 00816734022733 ()

  • Catheter Gauge: 17 French
HRAM-200

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022689

Zvu® HRiM Probe
DIVERSATEK HEALTHCARE, INC.
HRIM-201
In Commercial Distribution

  • 00816734022689 ()

  • Catheter Gauge: 12 French
HRIM-201

  • Manometric gastrointestinal motility analysis system

PREXION EVOLVE - 07899581345098

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

  • 07899581345098 ()
16000004498

  • Cone beam computed tomography system, head/neck

PREXION EVOLVE - 07899581345081

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

  • 07899581345081 ()
16000004497

  • Cone beam computed tomography system, head/neck

PREXION EVOLVE - 07899581345067

Tomography 0.2FS
Alliage S/A Indústrias Médico Odontológica
AXR90
In Commercial Distribution

  • 07899581345067 ()
16000004495

  • Cone beam computed tomography system, head/neck

SXR / Saevo - 07899581345043

Tomography with Cephalostat (MFOV)
Alliage S/A Indústrias Médico Odontológica
AXR90 B
In Commercial Distribution

  • 07899581345043 ()
16000004493

  • Cone beam computed tomography system, head/neck

SXR / Saevo - 07899581345029

Tomography with Cephalostat (MFOV)
Alliage S/A Indústrias Médico Odontológica
AXR90 B
In Commercial Distribution

  • 07899581345029 ()
16000004491

  • Cone beam computed tomography system, head/neck
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