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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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Propel Mini - M927600110

PROPEL Mini Sinus Implant
Intersect Ent, Inc.
60011
In Commercial Distribution

  • M927600110 ()

  • Stent Length: 18 Millimeter
  • Maximum Stent Diameter: 42.5 Millimeter


  • Paranasal sinus spacer

Propel Mini Straight Delivery System (SDS) Single Unit - M92710061

No Description
Intersect Ent, Inc.
10061
In Commercial Distribution

  • M92710061 ()
  • M92710065 ()


  • Paranasal sinus spacer

Propel Contour - M927500110

PROPEL Contour sinus implant
Intersect Ent, Inc.
50011
In Commercial Distribution

  • M927500110 ()

  • Stent Length: 8 Millimeter
  • Maximum Stent Diameter: 27 Millimeter


  • Paranasal sinus spacer

Stellarex - 00813132029173

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX060200135
In Commercial Distribution

  • 00813132029173 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060200135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028916

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX040040135
In Commercial Distribution

  • 00813132028916 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028893

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX060080080
In Commercial Distribution

  • 00813132028893 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132028879

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132028879 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024987

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 80cm
Spectranetics Corporation
AB35SX050100080
In Commercial Distribution

  • 00813132024987 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050100080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024970

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 80cm
Spectranetics Corporation
AB35SX040100080
In Commercial Distribution

  • 00813132024970 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040100080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132024291

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 135cm
Spectranetics Corporation
AB35SX060060135
In Commercial Distribution

  • 00813132024291 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060060135

  • Peripheral angioplasty balloon catheter, drug-coated
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