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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 - 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

Xact - 00854623006037

Mammography scar marker, 1cm perforations, 320 cm/box https://xactmarkers.com/product/scar-markers-m10lm/
Solstice Corporation
M10LM
In Commercial Distribution

  • 10854623006034 ()
  • 00854623006037 ()
M10LM

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

Xact - 00854623006020

BB marker, plastic, for Tomo/3D/CT, nipples and general marking, 2.3mm diameter,85/box https://xactmarkers.com/product/bb-markers-for-ct-m23sc/
Solstice Corporation
M23SC
In Commercial Distribution

  • 10854623006027 ()
  • 00854623006020 ()
M23SC

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

Xact - 00854623006013

Tomo/3Dimaging lesion marker, 10mm triangle,100/box https://xactmarkers.com/product/tomography-lesion-markers-2/
Solstice Corporation
M10TT
In Commercial Distribution

  • 10854623006010 ()
  • 00854623006013 ()
M10TT

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

Xact - 00854623006006

X-ray metal BB marker, 1.5mm diameter, lead free,120/box https://xactmarkers.com/product/nipple-markers-bb-markers-for-radiology-m15s/
Solstice Corporation
M15S
In Commercial Distribution

  • 10854623006003 ()
  • 00854623006006 ()
M15S

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

Nimbus II Plus - 00817170020161

Ambulatory infusion pump
INFUTRONIX LLC
Nimbus II Plus
In Commercial Distribution

  • 20817170020165 ()
  • 00817170020161 ()
  • 10817170020168 ()


  • Patient-controlled analgesia infusion pump
  • Ambulatory non-insulin infusion pump, electronic

Nimbus - 00817170020109

Ambulaotry infusion pump
INFUTRONIX LLC
Nimbus II EMS
In Commercial Distribution

  • 10817170020106 ()
  • 00817170020109 ()


  • Patient-controlled analgesia infusion pump
  • Ambulatory non-insulin infusion pump, electronic

Nimbus II PainPRO - 00817170020086

Ambulatory infusion pump
INFUTRONIX LLC
Nimbus II PainPRO
In Commercial Distribution

  • 10817170020083 ()
  • 00817170020086 ()
  • 20817170020080 ()
  • 30817170020087 ()
  • 40817170020084 ()
  • 50817170020081 ()


  • Patient-controlled analgesia infusion pump
  • Ambulatory non-insulin infusion pump, electronic

Nimbus - 00817170020000

Ambulatory infusion pump
INFUTRONIX LLC
Nimbus
In Commercial Distribution

  • 10817170020007 ()
  • 00817170020000 ()
  • 20817170020004 ()
  • 30817170020001 ()


  • Patient-controlled analgesia infusion pump
  • Ambulatory non-insulin infusion pump, electronic
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