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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
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
Barraquer New Born Eye Speculum, 5mm Closed Wire Blades With Dull Finish, 14mm Spread, And Overall Length Of 1 3/8" (36mm)
Med Saver, Inc.
5-5218-5
In Commercial Distribution

  • 00194613064754 ()


  • Eyelid speculum, reusable
Barraquer New Born Eye Speculum, 4mm Closed Wire Blades With Dull Finish, 14mm Spread, And Overall Length Of 1 3/8" (36mm)
Med Saver, Inc.
5-5218-4
In Commercial Distribution

  • 00194613010355 ()


  • Eyelid speculum, reusable
Barraquer New Born Short Eye Speculum, 3mm Closed Wire Blades With Dull Finish, 10mm Spread, And Overall Length Of 3/4" (20mm)
Med Saver, Inc.
5-5218-3
In Commercial Distribution

  • 00194613010348 ()


  • Eyelid speculum, reusable
A device that is attached to a wheelchair and used to mount accessories for wheelchair customization or to adapt to new requirements.
Pride Mobility Products Corp
WHEELCHAIR BRACKET
In Commercial Distribution

  • 00606509900119 ()
N/A

  • Wheelchair bracket/mount
POWER GUIDE 3N NEW PARALLELING GUIDE WITH MEASUREMENTS ON BOTH SIDES, CENTER TO CENTER DISTANCE, MEASUREMENTS, ALIGNMENT OF IMPLANTS, DRILL CONTROLLED ANGLE
Power Dental U.S.A. Inc.
1964N
In Commercial Distribution

  • D9431964N00 ()
1964N

  • Dressing/utility forceps, scissors-like, reusable
  • General-purpose calliper, metallic
PORTUX CAD/CAM Disc. 98.5X 20mm BL. ML
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0021867
In Commercial Distribution

  • 07701126710073 ()
0021867

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 20mm B1. ML
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0021864
In Commercial Distribution

  • 07701126710059 ()
0021864

  • Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 20mm A3. ML
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
0022078
In Commercial Distribution

  • 07701126710028 ()
0022078

  • Temporary dental crown/bridge resin
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