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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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Neuroguard IEP® System - 00851616007606

The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-0730-140-2
In Commercial Distribution

  • 00851616007606 ()
NG-0730-140-2

  • Bare-metal carotid artery stent
  • Carotid artery embolic protection system
  • Peripheral angioplasty balloon catheter, basic

Neuroguard IEP® System - 00851616007590

The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-0640-140-2
In Commercial Distribution

  • 00851616007590 ()
NG-0640-140-2

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent

Neuroguard IEP® System - 00851616007583

The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-0630-140-2
In Commercial Distribution

  • 00851616007583 ()
NG-0630-140-2

  • Bare-metal carotid artery stent
  • Carotid artery embolic protection system
  • Peripheral angioplasty balloon catheter, basic

COPAL® G+V - 04260102139855

COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone. It contains the aminoglycoside antibiotic gentamicin and the glycopeptide antibiotic vancomycin to protect the cured bone cement and surrounding tissue from colonization by bacteria that are sensitive to gentamicin and/or vancomycin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex(E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. COPAL® G+V is intended for single-use and is supplied sterile.
Heraeus Medical GmbH
1x40
In Commercial Distribution

  • 04260102139862 ()
  • 04260102139855 ()
  • 04260102139879 ()
5184267

  • Orthopaedic cement, antimicrobial
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