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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 RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F60020MR
In Commercial Distribution

  • 04540778157552 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 6.0 mm
BD-F60020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F50020MR
In Commercial Distribution

  • 04540778157538 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 5.0 mm
BD-F50020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F40020MR
In Commercial Distribution

  • 04540778157514 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 4.0 mm
BD-F40020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F30020MR
In Commercial Distribution

  • 04540778157491 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-F30020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F25020MR
In Commercial Distribution

  • 04540778157477 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-F25020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-F20020MR
In Commercial Distribution

  • 04540778157453 ()

  • 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; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-F20020MR

  • Peripheral angioplasty balloon catheter, basic
Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.
Sonic Incytes Medical Corp.
LI-1005
In Commercial Distribution

  • B995LI10050 ()


  • Hepatic ultrasound elastography system
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD
MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.
Meta Biomed Co., Ltd.
9213
In Commercial Distribution

  • 08806387892137 ()


  • Temporary dental crown/bridge
MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.
Meta Biomed Co., Ltd.
9212
In Commercial Distribution

  • 08806387892120 ()


  • Temporary dental crown/bridge
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