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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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Xeleris V Clinical Application SW
G E MEDICAL SYSTEMS ISRAEL LTD.
V
In Commercial Distribution

  • 00195278245021 ()


  • Nuclear medicine system workstation
The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit. Simsys is an image management system for the Siascope , which in addition to the features of the Molemate software, includes mole and lesion visualization and comprehensive patient image and data storage capabilities.
MedX Health Corp
V
In Commercial Distribution

  • 00628451918073 ()
  • 00628451918004 ()
  • 10628451918070 ()


  • Skin transilluminator, battery-powered
Molemate is a software management system for the SIAScope that displays five unique views: dermatoscopic, blood supply, pigment, dermal pigment and collagen.The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
MedX Health Corp
V
In Commercial Distribution

  • 00628451918004 ()
  • 00628451918035 ()
  • 10628451918032 ()


  • Skin transilluminator, battery-powered
No Description
Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda.
v
In Commercial Distribution

  • 07898325995605 ()


  • Resin artificial teeth
Bacterial Filter, noseclip and mouthpiece
S D I DIAGNOSTICS INC
V
In Commercial Distribution

  • B279F063908001 ()
  • B279F0639080 ()
F0639-080

  • Pulmonary function testing filter/mouthpiece
Pulmonary function bacterial filter
S D I DIAGNOSTICS INC
V
In Commercial Distribution

  • B279F060930002 ()
  • B279F0609300 ()
F0609-300

  • Pulmonary function testing filter/mouthpiece
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
V
In Commercial Distribution

  • 26939550822153 ()
  • 16939550822156 ()
  • 86939550822155 ()


  • Surgical penis clamp, single-use
No Description
Henan Tuoren Kingtaek Medical Device Co., Ltd.
V
In Commercial Distribution

  • 06970524032006 ()


  • Laryngoscope blade, single-use
A V FISTULA
Cardinal Health 200, LLC
SCV11HVL10
In Commercial Distribution

  • 50195594509963 ()
  • 10195594509965 ()
SCV11HVL10

  • Cardiothoracic surgical procedure kit, medicated, single-use
P V PACK
Cardinal Health 200, LLC
SCV38PVVA3
In Commercial Distribution

  • 50195594031723 ()
  • 10195594031725 ()
SCV38PVVA3

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
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