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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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microTargeting Insertion Tube with Stylet, nonsterile
FHC, INC.
66-IT(ES5)-00531
In Commercial Distribution

  • 00873263005316 ()

  • Outer Diameter: 2.12 Millimeter
  • Lumen/Inner Diameter: 1.89 Millimeter
  • Length: 190 Millimeter
66-IT(ES5)

  • Intracerebral cannula, implantable
microTargeting Insertion Tube with Stylet, nonsterile
FHC, INC.
66-IT(DB7)-00527
In Commercial Distribution

  • 00873263005279 ()

  • Length: 205.6 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
66-IT(DB7)

  • Intracerebral cannula, implantable
microTargeting Insertion Tube with Stylet, nonsterile
FHC, INC.
66-IT(DB3)-00523
In Commercial Distribution

  • 00873263005231 ()

  • Outer Diameter: 1.83 Millimeter
  • Length: 191.6 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
66-IT(DB3)

  • Intracerebral cannula, implantable
1D Dosimetry Water Phantom
CNMC CO., INC.
WP-3840
In Commercial Distribution

  • 00860321001410 ()
WP-3840

  • Multi-modality therapeutic radiation phantom, test object
1D Dosimetry Water Phantom.
CNMC CO., INC.
WP-3040 / WP-3840
In Commercial Distribution

  • 00860321001403 ()
WP-3040

  • Multi-modality therapeutic radiation phantom, test object
No Description
Silhouet-Tone Corporation
412004
Not in Commercial Distribution

  • 00667259000443 ()
  • 00667259000030 ()
412004

  • General examination/treatment chair, electric
MX12 Centrifuge; Digital, 24-place hematocrit (75mm), 12,000 rpm, reader disk, 220 volt
LW SCIENTIFIC, INC.
MHC-24HD-75T2
In Commercial Distribution

  • 00664816003534 ()


  • Microhaematocrit centrifuge IVD
MX12 Centrifuge; Digital, 24-place hematocrit (75mm), 12,000 rpm, reader disk, 110 volt
LW SCIENTIFIC, INC.
MHC-24HD-75T1
In Commercial Distribution

  • 00664816003527 ()


  • Microhaematocrit centrifuge IVD
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005854 ()
DSC017-04-US

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005601 ()
DSC017-01-US

  • Basic diagnostic x-ray system application software
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