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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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R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q30040ER
In Commercial Distribution

  • 04540778174993 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 3.0 mm
BD-Q30040ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q25040ER
In Commercial Distribution

  • 04540778174979 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 2.5 mm
BD-Q25040ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q20040ER
In Commercial Distribution

  • 04540778174955 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 2.0 mm
BD-Q20040ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q60020ER
In Commercial Distribution

  • 04540778174931 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 6.0 mm
BD-Q60020ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q50020ER
In Commercial Distribution

  • 04540778174917 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-Q50020ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q40020ER
In Commercial Distribution

  • 04540778174894 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-Q40020ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q30020ER
In Commercial Distribution

  • 04540778174870 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-Q30020ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q25020ER
In Commercial Distribution

  • 04540778174856 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-Q25020ER

  • Peripheral angioplasty balloon catheter, basic
R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-Q20020ER
In Commercial Distribution

  • 04540778174832 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-Q20020ER

  • Peripheral angioplasty balloon catheter, basic
R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
KANEKA CORPORATION
BD-P70200ER
In Commercial Distribution

  • 04540778167155 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 7.0 mm
BD-P70200ER

  • Peripheral angioplasty balloon catheter, basic
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