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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 - M927700110

Propel sinus implant
Intersect Ent, Inc.
70011
In Commercial Distribution

  • M927700110 ()

  • Stent Length: 25 Millimeter
  • Maximum Stent Diameter: 50 Millimeter


  • Paranasal sinus spacer

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

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 - 00813132029166

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX060150135
In Commercial Distribution

  • 00813132029166 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029159

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050200135
In Commercial Distribution

  • 00813132029159 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050200135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029142

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX050150135
In Commercial Distribution

  • 00813132029142 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029135

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX040200135
In Commercial Distribution

  • 00813132029135 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040200135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029128

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 135cm
Philips Image Guided Therapy Corporation
AB35SX040150135
In Commercial Distribution

  • 00813132029128 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 150 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132029111

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 80cm
Philips Image Guided Therapy Corporation
AB35SX060200080
In Commercial Distribution

  • 00813132029111 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060200080

  • Peripheral angioplasty balloon catheter, drug-coated
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