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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Monarch™ Laptop P17/P73 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810506 ()


  • Robotic surgical system application software
Monarch™ Laptop P70 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810490 ()


  • Robotic surgical system application software
Monarch™ Software Cart v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810483 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810476 ()


  • Robotic surgical system application software
1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle.
Izi Medical Products, LLC
VC-110-030-PL
In Commercial Distribution

  • B887VC110030PL0 ()
VC-110-030-PL

  • Radiological image marker, implantable
1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-020-PL30
In Commercial Distribution

  • B887VC110020PL300 ()
VC-110-020-PL30

  • Radiological image marker, implantable
1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-020-PL
In Commercial Distribution

  • B887VC110020PL0 ()
VC-110-020-PL

  • Radiological image marker, implantable
1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-010-PL30
In Commercial Distribution

  • B887VC110010PL300 ()
VC-110-010-PL30

  • Radiological image marker, implantable
1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-010-PL
In Commercial Distribution

  • B887VC110010PL0 ()
VC-110-010-PL

  • Radiological image marker, implantable
1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-005-PL
In Commercial Distribution

  • B887VC110005PL0 ()
VC-110-005-PL

  • Radiological image marker, implantable
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