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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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eSensor® XT-8 - 00857167005153

eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex

eSensor® XT-8 - 00857167005061

eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005061 ()
MT002000

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

ULTRA SEAL LINER - 00713980034964

Ultra Seal High Ring Cushion Liner Size 24
Alps South, LLC
USHSC24
In Commercial Distribution

  • 00713980034964 ()


  • External limb prosthesis socket liner

BIOSTEP XT - 00713980027768

BioStep XT, Size 24, Right, Rate 62, Dark
Alps South, LLC
BSXT-24R-62D
In Commercial Distribution

  • 00713980027768 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP XT - 00713980027706

BioStep XT, Size 24, Right, Rate 32, Dark
Alps South, LLC
BSXT-24R-32D
In Commercial Distribution

  • 00713980027706 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP XT - 00713980027669

BioStep XT, Size 24, Right, Rate 22, Dark
Alps South, LLC
BSXT-24R-22D
In Commercial Distribution

  • 00713980027669 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP XT - 00713980027621

BioStep XT, Size 24, Right, Rate 11, Dark
Alps South, LLC
BSXT-24R-11D
In Commercial Distribution

  • 00713980027621 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP XT - 00713980027607

BioStep XT, Size 24, Left, Rate 62, Dark
Alps South, LLC
BSXT-24L-62D
In Commercial Distribution

  • 00713980027607 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP XT - 00713980027546

BioStep XT, Size 24, Left, Rate 32, Dark
Alps South, LLC
BSXT-24L-32D
In Commercial Distribution

  • 00713980027546 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP XT - 00713980027485

BioStep XT, Size 24, Left, Rate 21, Dark
Alps South, LLC
BSXT-24L-21D
In Commercial Distribution

  • 00713980027485 ()


  • Mechanical-resistance external ankle-foot prosthesis
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