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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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alpHaONE - 06946332800045

pH capsule, 1 pack
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 06946332800625 ()
  • 06946332800045 ()
  • 06946332800632 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

NuVaMap - 00887517695505

NuVaMap O.R. Calibration Sphere
Nuvasive, Inc.
8210347
In Commercial Distribution

  • 00887517695505 ()


  • Spinal rod bending system

Bio30+ System Physio HR - 05056336800260

Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-56
In Commercial Distribution

  • 05056336800260 ()


  • Amino acid analyser IVD

Bio30+ System Physio HP - 05056336800222

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-53
In Commercial Distribution

  • 05056336800222 ()


  • Amino acid analyser IVD

Bindex Measure - 06430065790020

Measuring stick for defining the standard location for Bindex measurement.
Bone Index Finland Oy
BI-41
In Commercial Distribution

  • 06430065790020 ()


  • Bone absorptiometric ultrasound system

BIOSTEP XT - 00713980034377

Prostride Microprocessor Controlled Knee
Alps South, LLC
PSMPK
In Commercial Distribution

  • 00713980034377 ()


  • Mechatronic external knee prosthesis

KXL System - 00855574003083

No Description
AVEDRO, INC.
110-02724
In Commercial Distribution

  • 00855574003083 ()


  • Ophthalmic crosslinking ultraviolet phototherapy system

KXL System - 00855574003007

No Description
AVEDRO, INC.
110-02723
In Commercial Distribution

  • 00855574003007 ()


  • Ophthalmic crosslinking ultraviolet phototherapy system

InnerView® System Base Station - 00860011518310

InnerView System Base Station
Perimetrics, Inc.
INV-2000
In Commercial Distribution

  • 00860011518310 ()
INV-2000

  • Dental stability percussive analysis handpiece

InnerView® System Handpiece - 00860011518303

QPD Measurement Instrument
Perimetrics, Inc.
INV-1000
In Commercial Distribution

  • 00860011518303 ()
INV-1000

  • Dental stability percussive analysis handpiece
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