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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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Xper Flex Cardio 2020 Rev E Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev E Exchange
Not in Commercial Distribution

  • 00884838093782 ()
453564845861

  • General-purpose multi-parameter bedside monitor
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set
No Description
Merit Medical Systems, Inc.
00884450239476
In Commercial Distribution

  • 10884450239473 ()
  • 00884450239476 ()
  • 20884450239470 ()

  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA502

  • Cardiac/peripheral vascular guidewire, single-use
No Description
Merit Medical Systems, Inc.
00884450198827
In Commercial Distribution

  • 20884450198821 ()
  • 10884450198824 ()
  • 00884450198827 ()

  • Length-260 cm (102")
  • Tip Shape-1.5 mm J-Tip
  • Configuration-Standard Exchange
  • Tip Shape-1.5 mm J-Tip; Length-260 cm (102"); Tip Shape-1.5 mm J-Tip; Configuration-Standard Exchange
  • Configuration-Standard Exchange; Length-260 cm (102"); Tip Shape-1.5 mm J-Tip; Configuration-Standard Exchange
IQ35F260J1O5/B

  • Cardiac/peripheral vascular guidewire, single-use
No Description
Merit Medical Systems, Inc.
00884450011133
In Commercial Distribution

  • 20884450011137 ()
  • 10884450011130 ()
  • 00884450011133 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip
  • Configuration-Standard Exchange; Length-260 cm (102"); Configuration-Standard Exchange; Tip Shape-3 mm J-Tip
  • Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Standard Exchange; Tip Shape-3 mm J-Tip
IQ35F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use
No Description
Merit Medical Systems, Inc.
00884450004333
In Commercial Distribution

  • 20884450004337 ()
  • 10884450004330 ()
  • 00884450004333 ()

  • Length-260 cm (102")
  • Tip Shape-3 mm J-Tip
  • Configuration-Standard Exchange
  • Configuration-Standard Exchange; Length-260 cm (102"); Tip Shape-3 mm J-Tip; Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip; Length-260 cm (102"); Tip Shape-3 mm J-Tip; Configuration-Standard Exchange
IQ38F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use
Fracture alignment guide wire exchange tool, Hudson joint
CITIEFFE SRL
Fracture align. guide wire exchange tool, Hudson
In Commercial Distribution

  • 08059386743072 ()
DT030016

  • Orthopaedic bone-fragment manipulator, reusable
REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4MM 0 DEGREES WIDE
Gyrus ACMI, LLC
REX70230910
In Commercial Distribution

  • 00821925027114 ()


  • Rigid optical sinoscope
REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 0 DEGREE
Gyrus ACMI, LLC
REX23-5210
In Commercial Distribution

  • 00821925027411 ()


  • Otoscope, endoscopic
REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 30 DEGREES
Gyrus ACMI, LLC
REX23-5201
In Commercial Distribution

  • 00821925027213 ()


  • Otoscope, endoscopic
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