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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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EVA SELECT SIZE 1 SYSTEM
ImageWorks
9992412100
In Commercial Distribution

  • D83399924121000 ()
9992412100

  • Dental digital imaging sensor, intraoral
  • General-purpose dental x-ray system application software
EVA SELECT DIRECT SIZE 2 SYSTEM
ImageWorks
9992413200
In Commercial Distribution

  • D83399924132000 ()
9992413200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral
EVA SELECT DIRECT SIZE 1 SENSOR ONLY
ImageWorks
9992413105
In Commercial Distribution

  • D83399924131050 ()
9992413105

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral
EVA SELECT DIRECT SIZE 1 SYSTEM
ImageWorks
9992413100
In Commercial Distribution

  • D83399924131000 ()
9992413100

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral
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 B3. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0023315
In Commercial Distribution

  • 07701126712107 ()
0023315

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X30mm D2. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0024940
In Commercial Distribution

  • 07701126712084 ()
0024940

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 30mm C2. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0024939
In Commercial Distribution

  • 07701126712077 ()
0024939

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X30mm C1. MN
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0024938
In Commercial Distribution

  • 07701126712060 ()
0024938

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 30mm D2. ML
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0024872
In Commercial Distribution

  • 07701126712046 ()
0024872

  • Temporary dental crown/bridge resin
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