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 1cm Gold Fiducial Marker Pre-Loaded Needle 22g x 20cm
Izi Medical Products, LLC
SN-035-010-PL20
In Commercial Distribution

  • B887SN035010PL200 ()
SN-035-010-PL20

  • Radiological image marker, implantable
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

  • B887SN035010PL150 ()
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

  • B887SN035010PL080 ()
SN-035-010-PL08

  • Radiological image marker, implantable
0.35mm x 0.5cm Gold Fiducial Marker Pre-Loaded Needle 22g x 20cm
Izi Medical Products, LLC
SN-035-005-PL20
In Commercial Distribution

  • B887SN035005PL200 ()
SN-035-005-PL20

  • 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

  • B887SN035005PL150 ()
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

  • B887SN035005PL080 ()
SN-035-005-PL08

  • Radiological image marker, implantable
0.35mm x 2cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-020-22
In Commercial Distribution

  • B887SHZ035020220 ()
SHZ-035-020-22

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-010-22
In Commercial Distribution

  • B887SHZ035010220 ()
SHZ-035-010-22

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-005-22
In Commercial Distribution

  • B887SHZ035005220 ()
SHZ-035-005-22

  • Radiological image marker, implantable
Visicoil Multi-Market Patient Convenience Kit: Quantity of 1: SNMR-050-005-2120 and Quantity of 1: PTTL-050-11021
Izi Medical Products, LLC
KIT-PTN-3MR
Not in Commercial Distribution

  • B887LITPTN3MR0 ()
KIT-PTN-3MR

  • Radiological image marker, implantable
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