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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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The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: Linear distance measurements of anatomical structures, Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies, Measurement of brightness ratio between structures and in particular between the liver and the kidney, Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution

  • 03770023859011 ()


  • Ultrasound imaging system application software
  • Hepatic ultrasound elastography system
PORTUX CAD/CAM Disc. 98.5X 18mm BL3. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0026536
In Commercial Distribution

  • 07701126713586 ()
0026536

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X30mm. Meharry Dental Base
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0026110
In Commercial Distribution

  • 07701126713494 ()
0026110

  • Dental appliance fabrication material, resin
PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. ML
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0022212
In Commercial Distribution

  • 07701126713364 ()
0022212

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X25mm D3. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023338
In Commercial Distribution

  • 07701126712350 ()
0023338

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 20mm D3. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023337
In Commercial Distribution

  • 07701126712343 ()
0023337

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 18mm D3. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023336
In Commercial Distribution

  • 07701126712336 ()
0023336

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X18mm D2. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023333
In Commercial Distribution

  • 07701126712312 ()
0023333

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 18mm C2. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023324
In Commercial Distribution

  • 07701126712299 ()
0023324

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 25mm C1. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023323
In Commercial Distribution

  • 07701126712282 ()
0023323

  • Temporary dental crown/bridge resin
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