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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0.35mm x 1.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-035-010-PL15
In Commercial Distribution

  • EIBASN035010PL150 ()
SN-035-010-PL15

  • Radiological image marker, implantable
0.35mm x 1.0cm Visicoil loaded into a pre-waxed 22 gauge brachytherapy needle.
Izi Medical Products, LLC
SN-035-010-PL08
In Commercial Distribution

  • EIBASN035010PL080 ()
SN-035-010-PL08

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL loaded into an 22g pre-waxed needle.
Izi Medical Products, LLC
SN-035-005-PL15
In Commercial Distribution

  • EIBASN035005PL150 ()
SN-035-005-PL15

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL loaded into an 22 gauge pre-waxed needle.
Izi Medical Products, LLC
SN-035-005-PL08
In Commercial Distribution

  • EIBASN035005PL080 ()
SN-035-005-PL08

  • Radiological image marker, implantable
Visicoil Multi-Market Patient Convenience Kit: Quantity of 8: SN-050-005-PL08. Which contains: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
KIT-SPN-8PL
In Commercial Distribution

  • EIBAKITSPN8PL0 ()
KIT-SPN-8PL

  • Radiological image marker, implantable
This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.
CANON MEDICAL SYSTEMS CORPORATION
PCD-1000A
In Commercial Distribution

  • 04987670103810 ()


  • PET/CT system
Mobile multimodality cone beam computed tomography scanner.
EPICA HUMAN HEALTH LLC
9801101000
In Commercial Distribution

  • 00860012510900 ()


  • Cone beam computed tomography system, head/neck
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Epica Medical Innovations LLC
SeeFactorCT3
Not in Commercial Distribution

  • 00860005941605 ()
860005941605

  • Cone beam computed tomography system, head/neck
No Description
Philips Medical Systems Nederland B.V.
Vereos PET/CT System Upgrade
In Commercial Distribution

  • 00884838108103 ()
882425

  • PET/CT system
No Description
Philips Medical Systems Nederland B.V.
Vereos PET/CT
In Commercial Distribution

  • 00884838059559 ()
882446

  • PET/CT system
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