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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0.8mm x 3mm Gold Fiducial Marker Loose
Izi Medical Products, LLC
GF0302
In Commercial Distribution

  • B887GF03020 ()
GF0302

  • Radiological image marker, implantable
0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
Izi Medical Products, LLC
SNMR-035-030-2220
In Commercial Distribution

  • B887SNMR03503022200 ()
SNMR-035-030-2220

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
Izi Medical Products, LLC
SNMR-035-020-2220
In Commercial Distribution

  • B887SNMR03502022200 ()
SNMR-035-020-2220

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SNMR-035-020-2215
In Commercial Distribution

  • B887SNMR03502022150 ()
SNMR-035-020-2215

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
Izi Medical Products, LLC
SNMR-035-020-2208
In Commercial Distribution

  • B887SNMR03502022080 ()
SNMR-035-020-2208

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
Izi Medical Products, LLC
SNMR-035-010-2220
In Commercial Distribution

  • B887SNMR03501022200 ()
SNMR-035-010-2220

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SNMR-035-010-2215
In Commercial Distribution

  • B887SNMR03501022150 ()
SNMR-035-010-2215

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
Izi Medical Products, LLC
SNMR-035-010-2208
In Commercial Distribution

  • B887SNMR03501022080 ()
SNMR-035-010-2208

  • Radiological image marker, implantable
0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-020-PL15
In Commercial Distribution

  • B887SN050020PL150 ()
SN-050-020-PL15

  • Radiological image marker, implantable
0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-020-PL08
In Commercial Distribution

  • B887SN050020PL080 ()
SN-050-020-PL08

  • Radiological image marker, implantable
0.5mm x 1cm Gold Fiducial Marker Pre-Loaded Needle 21g x 20cm
Izi Medical Products, LLC
SN-050-010-PL20
In Commercial Distribution

  • B887SN050010PL200 ()
SN-050-010-PL20

  • Radiological image marker, implantable
0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-010-PL15
In Commercial Distribution

  • B887SN050010PL150 ()
SN-050-010-PL15

  • Radiological image marker, implantable
0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-005-PL15
In Commercial Distribution

  • B887SN050005PL150 ()
SN-050-005-PL15

  • Radiological image marker, implantable
0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-005-PL08
In Commercial Distribution

  • B887SN050005PL080 ()
SN-050-005-PL08

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-035-020-PL15
In Commercial Distribution

  • B887SN035020PL150 ()
SN-035-020-PL15

  • Radiological image marker, implantable
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
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
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

  • B887KITSPN8PL0 ()
KIT-SPN-8PL

  • 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
In Commercial Distribution

  • B887KITPTN3MR0 ()
KIT-PTN-3MR

  • Radiological image marker, implantable
4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
Izi Medical Products, LLC
GF15334
In Commercial Distribution

  • B887GF15340 ()
GF1534

  • Radiological image marker, implantable
1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle.
Izi Medical Products, LLC
GF1531
In Commercial Distribution

  • B887GF15310 ()
GF1531

  • Radiological image marker, implantable
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports.
MEDIAN TECHNOLOGIES
6.0
In Commercial Distribution

  • 03760263520017 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300367 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
2.0
In Commercial Distribution

  • 08800025300299 ()


  • Radiological PACS software
No Description
CORELINE SOFT CO.,LTD.
1.1
In Commercial Distribution

  • 08800025300237 ()


  • Radiological PACS software
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