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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, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 7.0mm x 12mm
Verge Medical, Inc.
OTW7012BA
In Commercial Distribution

  • M917OTW7012BA0 ()

  • Distal Balloon Diameter: 7.0mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OTW7012BA

  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 6.0mm x 12mm
Verge Medical, Inc.
OTW6012BA
In Commercial Distribution

  • M917OTW6012BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 6.0mm
OTW6012BA

  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 7.0mm x 17mm
Verge Medical, Inc.
OAB7019BA
In Commercial Distribution

  • M917OAB7019BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 7.0mm
OAB7019BA

  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 17mm
Verge Medical, Inc.
OAB6019BA
In Commercial Distribution

  • M917OAB6019BA0 ()

  • Distal Balloon Diameter: 6.0mm
  • Distal Balloon Length: 17mm
  • Catheter Length: 135cm
OAB6019BA

  • Peripheral angioplasty balloon catheter, basic
FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 12mm
Verge Medical, Inc.
OAB6014BA
In Commercial Distribution

  • M917OAB6014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 6.0mm
OAB6014BA

  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060120OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060080OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060040OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060020OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812055120OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
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