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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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CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F40020MW
In Commercial Distribution

  • 04540778160514 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-F40020MW

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F30020MW
In Commercial Distribution

  • 04540778160491 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-F30020MW

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F25020MW
In Commercial Distribution

  • 04540778160477 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-F25020MW

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F20020MW
In Commercial Distribution

  • 04540778160453 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-F20020MW

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F20060LW
In Commercial Distribution

  • 04540778161658 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 60 mm
  • Balloon Diameter; 2.0 mm
BD-F20060LW

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F50040LW
In Commercial Distribution

  • 04540778161610 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 5.0 mm
BD-F50040LW

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).
KANEKA CORPORATION
BD-F40040LW
In Commercial Distribution

  • 04540778161597 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Shaft Diameter; 3.9 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 40 mm
  • Balloon Diameter; 4.0 mm
BD-F40040LW

  • Peripheral angioplasty balloon catheter, basic
Trel-XPress 300c, 2.5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c25
In Commercial Distribution

  • 10381780112594 ()
  • M386XPRES3C251 ()

  • 2.5cc
XPres3c25

  • Bone matrix implant, human-derived
Trel-XPress 300c, 5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c05
In Commercial Distribution

  • 10381780112587 ()
  • M386XPRES3C051 ()

  • 5cc
XPres3c05

  • Bone matrix implant, human-derived
Trel-XPress 300c, 10cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c10
In Commercial Distribution

  • M386XPRES3C101 ()
  • 10381780112570 ()

  • 10cc
XPres3c10

  • Bone matrix implant, human-derived
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