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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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Xact - 00854623006143

Mammography area of concern marker, 10mm square, 80/box https://xactmarkers.com/product/tomosynthesis-area-of-concern-markers/
Solstice Corporation
M10AC
In Commercial Distribution

  • 10854623006140 ()
  • 00854623006143 ()
M10AC

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006136

X-ray imaging marker for extremities, 15mm circle, 60/box https://xactmarkers.com/product/skeletal-ring-markers-m15r/
Solstice Corporation
M15R
In Commercial Distribution

  • 10854623006133 ()
  • 00854623006136 ()
M15R

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006129

X-ray imaging marker for extremities, 10mm circle, 60/box https://xactmarkers.com/product/skeletal-ring-markers-part-m10r/
Solstice Corporation
M10R
In Commercial Distribution

  • 10854623006126 ()
  • 00854623006129 ()
M10R

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006112

Mammography lesion marker, 10mm triangle,120/box https://xactmarkers.com/product/lesion-markers-m10tm/
Solstice Corporation
M10TM
In Commercial Distribution

  • 10854623006119 ()
  • 00854623006112 ()
M10TM

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006105

BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.0mm diameter,100/box https://xactmarkers.com/product/2-0mm-tomosynthesisct-bb-markers/
Solstice Corporation
M20SC
In Commercial Distribution

  • 10854623006102 ()
  • 00854623006105 ()
M20SC

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006099

BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 1.5mm diameter,100/box https://xactmarkers.com/product/1-5mm-tomosynthesisct-bb-markers/
Solstice Corporation
M15SC
In Commercial Distribution

  • 10854623006096 ()
  • 00854623006099 ()
M15SC

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006082

X-ray metal BB marker, 2.0mm diameter, lead free,120/box https://xactmarkers.com/product/nipple-markers-bb-markers-for-radiology-m20s/
Solstice Corporation
M20S
In Commercial Distribution

  • 10854623006089 ()
  • 00854623006082 ()
M20S

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006068

Mammography mole marker, 15mm circle,100/box https://xactmarkers.com/product/mole-markers-m15rm/
Solstice Corporation
M15RM
In Commercial Distribution

  • 10854623006065 ()
  • 00854623006068 ()
M15RM

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006051

Tomo/3D imaging mole marker, 15mm circle,80/box https://xactmarkers.com/product/tomography-mole-markers/
Solstice Corporation
M15RT
In Commercial Distribution

  • 10854623006058 ()
  • 00854623006051 ()
M15RT

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use

Xact - 00854623006044

Tomo/3D imaging scar marker, 1cm perforations, 300 cm/box https://xactmarkers.com/product/tomography-scar-markers/
Solstice Corporation
M10LT
In Commercial Distribution

  • 10854623006041 ()
  • 00854623006044 ()
M10LT

  • Radiographic image marker, manual
  • Imaging lesion localization marker, external, single-use
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