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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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Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5830-020-32
In Commercial Distribution

  • 06934955932151 ()
5830-020-32

  • Peripheral angioplasty balloon catheter, basic
Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5830-015-32
In Commercial Distribution

  • 06934955932144 ()
5830-015-32

  • Peripheral angioplasty balloon catheter, basic
Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5825-300-32
In Commercial Distribution

  • 06934955932137 ()
5825-300-32

  • Peripheral angioplasty balloon catheter, basic
Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5825-240-32
In Commercial Distribution

  • 06934955932120 ()
5825-240-32

  • Peripheral angioplasty balloon catheter, basic
Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5825-180-32
In Commercial Distribution

  • 06934955932113 ()
5825-180-32

  • Peripheral angioplasty balloon catheter, basic
Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5825-150-32
In Commercial Distribution

  • 06934955932106 ()
5825-150-32

  • Peripheral angioplasty balloon catheter, basic
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW
OrbusNeich Medical (ShenZhen) Co., Ltd.
5825-120-32
In Commercial Distribution

  • 06934955932090 ()
5825-120-32

  • Peripheral angioplasty balloon catheter, basic
Percutaneous Transluminal Angioplasty Balloon Catheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
5825-100-32
In Commercial Distribution

  • 06934955932083 ()
5825-100-32

  • Peripheral angioplasty balloon catheter, basic
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-LX0020MR
In Commercial Distribution

  • 04540778151116 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 7 Fr
  • Rated Burst Pressure; 12 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.9 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 10.0 mm
BD-LX0020MR

  • Peripheral angioplasty balloon catheter, basic
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. 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-L90020MR
In Commercial Distribution

  • 04540778151093 ()

  • Maximum Guidewire Diameter; 0.035 inch
  • Compatible Sheath Diameter; 7 Fr
  • Rated Burst Pressure; 12 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.9 Fr
  • Distal Shaft Diameter; 5.7 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 9.0 mm
BD-L90020MR

  • Peripheral angioplasty balloon catheter, basic
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