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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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FLASH Ostial System - M917OCB4514BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.5mm x 12mm
Verge Medical, Inc.
OCB4514BA
In Commercial Distribution

  • M917OCB4514BA0 ()

  • Distal Balloon Diameter: 4.5mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OCB4514BA

  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OCB4014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm
Verge Medical, Inc.
OCB4014BA
In Commercial Distribution

  • M917OCB4014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 4.0mm
OCB4014BA

  • Peripheral angioplasty balloon catheter, basic
  • Coronary angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942327

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
230-123-5UU
In Commercial Distribution

  • 06934955942327 ()

  • Outer Diameter: 3.0 Millimeter
  • Length: 12 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942310

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
230-103-5UU
In Commercial Distribution

  • 06934955942310 ()

  • Length: 10 Millimeter
  • Outer Diameter: 3.0 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942297

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
227-153-5UU
In Commercial Distribution

  • 06934955942297 ()

  • Length: 15 Millimeter
  • Outer Diameter: 2.75 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942273

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
225-303-5UU
In Commercial Distribution

  • 06934955942273 ()

  • Length: 30 Millimeter
  • Outer Diameter: 2.5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942259

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
225-153-5UU
In Commercial Distribution

  • 06934955942259 ()

  • Length: 15 Millimeter
  • Outer Diameter: 2.5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942235

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
225-103-5UU
In Commercial Distribution

  • 06934955942235 ()

  • Length: 10 Millimeter
  • Outer Diameter: 2.5 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942228

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
222-203-5UU
In Commercial Distribution

  • 06934955942228 ()

  • Outer Diameter: 2.25 Millimeter
  • Length: 20 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic

Sapphire II Pro - 06934955942204

Balloon Dilatation Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
222-103-5UU
In Commercial Distribution

  • 06934955942204 ()

  • Outer Diameter: 2.25 Millimeter
  • Length: 10 Millimeter


  • Coronary angioplasty balloon catheter, basic
  • Peripheral angioplasty balloon catheter, basic
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