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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

Dealmed - 00859140003125

Cold Pack Disposable 4" x 5", 24/Cs
DEALMED MEDICAL SUPPLIES LLC
787520
In Commercial Distribution

  • 10859140003122 ()
  • 00859140003125 ()
787520

  • Hot/cold therapy pack, single-use

AMC - 00849593007993

5 Lead Spacelabs Tru-Link 90496 to Pinch, 24"
Advantage Medical Electronics, LLC
LWM-3500024/5A
In Commercial Distribution

  • 00849593007993 ()


  • Electrocardiographic lead set, reusable

AMC - 00849593006248

3 Lead Safety DIN to Snap, 24", AHA
Advantage Medical Electronics, LLC
LWM-2090024/3A
In Commercial Distribution

  • 00849593006248 ()


  • Electrocardiographic lead set, reusable

AMC - 00849593001151

5 Lead Spacelabs Tru-Link 90496 to Pinch, 24"
Advantage Medical Electronics, LLC
LW-3500024/5A
In Commercial Distribution

  • 00849593001151 ()


  • Electrocardiographic lead set, reusable

ALEUTIAN® Interbody Systems - 10888857120426

Lordotic AN Inserter, Shaft, Size Shaft - 24 mm
K2M, INC.
602-90760
In Commercial Distribution

  • 10888857120426 ()

  • Length: 24 Millimeter
602-90760

  • Orthopaedic prosthesis implantation positioning instrument, reusable

AMC - 00849593030083

3 Lead Safety DIN to Snap, 24" H
Advantage Medical Electronics, LLC
LW-2090024/3H
In Commercial Distribution

  • 00849593030083 ()


  • Electrocardiographic lead set, reusable

AMC - 00849593030076

3 Lead Safety DIN to Snap, 24", AHA
Advantage Medical Electronics, LLC
LW-2090024/3A
In Commercial Distribution

  • 00849593030076 ()


  • Electrocardiographic lead set, reusable

RAVINE Lateral Access System - 10888857243613

Lateral Access Blade Size 24 x 160 mm
K2M, INC.
K2-27-2001-10
In Commercial Distribution

  • 10888857243613 ()
K2-27-2001-10

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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