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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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The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
oncoReveal CDx - Kit (Boxes 1 through 4)
Pillar Biosciences, Inc.
HDA-LC-2001-48
In Commercial Distribution

  • 00860001218282 ()
HDA-LC-2001-4

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 4 of 4. This box contains extra white and orange caps for reagents.
Pillar Biosciences, Inc.
HDA-LC-2001-48-4
In Commercial Distribution

  • 00860001218251 ()
HDA-LC-2001-48-4

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 3 of 4. This box contains Purification Beads.
Pillar Biosciences, Inc.
HDA-LC-2001-48-3
In Commercial Distribution

  • 00860001218244 ()
HDA-LC-2001-48-3

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
Pillar Biosciences, Inc.
HDA-LC-2001-48-1
In Commercial Distribution

  • 00860001218220 ()
HDA-LC-2001-48-1

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
No Description
Resolution Bioscience, Inc.
500029
Not in Commercial Distribution

  • 00850059806005 ()


  • Venous blood collection kit IVD
MasteRad MX-30 Radiographic System
Medicatech Usa, Inc.
MasteRad MX30
In Commercial Distribution

  • 00860001404753 ()
MasteRad MX30

  • Stationary basic diagnostic x-ray system, digital
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