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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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MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021874 ()

  • Width: 7.75 Inch
7025-300E

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021867 ()

  • Width: 7.75 Inch
7025-300D

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021850 ()

  • Width: 7.75 Inch
7025-300B

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-1.1
In Commercial Distribution

  • 00858526006736 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer
The PRC Look™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400 and Accent 1000, now you can access the full communication & computing power with just your eyes! The PRC Look™ Tracking System attaches quickly to the Accent 1400 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.
PRENTKE ROMICH COMPANY
PRCL-1
In Commercial Distribution

  • 00858526006699 ()

  • Weight: .10 Pound


  • Voice synthesizer/digitizer
ComPel Surgical Gown, 2-Ply Front Beryl Green ComPel I, 2-Ply Beryl Green ComPel I Sleeves, Comfort Panel Back Panels with Carbon, Color Coded ComPel Neck Binding, Tape Tie Closures at Neck and Waist, QCM, Size Large
STANDARD TEXTILE CO., INC.
75614305
In Commercial Distribution

  • 00634916691658 ()
  • 10634916691655 ()
75614305

  • 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, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601674
In Commercial Distribution

  • 00690286000315 ()
  • 10690286000312 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The xTAG® Cystic Fibrosis 60 Kit v2 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
I024C0181
In Commercial Distribution

  • 00840487100479 ()
I024C0181

  • Cystic fibrosis IVD, kit, multiplex
The xTAG® Cystic Fibrosis 39 Kit v2 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
I027C0231
In Commercial Distribution

  • 00840487100141 ()
I027C0231

  • Cystic fibrosis IVD, kit, multiplex
Neg Urine Combo 103
Beckman Coulter, Inc.
C89645
In Commercial Distribution

  • 05099590753859 ()
  • 15099590765385 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
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