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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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D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_9090_B1_N
In Commercial Distribution

  • 03664049001038 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_AT_PA_NV2
In Commercial Distribution

  • 03664049000062 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_B1_NV2
In Commercial Distribution

  • 03664049000055 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_AT_PA
In Commercial Distribution

  • 03664049000048 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
STEPHANIX
D2RS_B1_N
In Commercial Distribution

  • 03664049000031 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
Opgen, Inc.
KT03U01-1
Not in Commercial Distribution

  • 20812125010000 ()
KT03U01-1

  • Microplate IVD
  • Assay adhesive sealing/fixation film IVD
ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Size 2XL
STANDARD TEXTILE CO., INC.
75615073
In Commercial Distribution

  • 10634916819042 ()
  • 00634916819045 ()


  • Surgical gown, reusable
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601684
In Commercial Distribution

  • 00690286000780 ()
  • 10690286000787 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604022
In Commercial Distribution

  • 00690286000049 ()
  • 10690286000046 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens
Luminex Molecular Diagnostics, Inc
I006C0068
Not in Commercial Distribution

  • 00840487100455 ()
I006C0068

  • Cystic fibrosis IVD, kit, multiplex
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