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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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No Description
XORAN TECHNOLOGIES LLC
10040
In Commercial Distribution

  • 00860008443755 ()


  • Cone beam computed tomography system, head/neck
No Description
XORAN TECHNOLOGIES LLC
10015
In Commercial Distribution

  • 00860008443731 ()


  • Cone beam computed tomography system, head/neck
TRON is a mobile, open bore, fluoroscope and cone beam computed tomography system designed for high-resolution bone window and soft tissue imaging of anatomy that fits within the imaging aperture.
XORAN TECHNOLOGIES LLC
11050
In Commercial Distribution

  • 00860008443700 ()


  • Mobile general-purpose fluoroscopic x-ray system, digital
No Description
Brazen Goods Inc.
Shortie
In Commercial Distribution

  • 00860008392121 ()
  • 00860008392176 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Bikini
In Commercial Distribution

  • 00860008392138 ()
  • 00860008392169 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Shortie
In Commercial Distribution

  • 00860008392121 ()
  • 00860008392152 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Bikini
In Commercial Distribution

  • 00860008392138 ()
  • 00860008392145 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Shortie
In Commercial Distribution

  • 00860008392114 ()
  • 00860008392121 ()


  • Oral/vaginal sex barrier, Hevea-latex
No Description
Brazen Goods Inc.
Bikini
In Commercial Distribution

  • 00860008392107 ()
  • 00860008392138 ()


  • Oral/vaginal sex barrier, Hevea-latex
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321374 ()
6101BR Size 2 Replacement

  • Dental digital imaging sensor, intraoral
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