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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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Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20243-0815P
Not in Commercial Distribution

  • 09421904065970 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20143-2020P
Not in Commercial Distribution

  • 09421904065963 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20143-0820P
Not in Commercial Distribution

  • 09421904065956 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20143-1620P
Not in Commercial Distribution

  • 09421904065949 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
R20143-0416P
Not in Commercial Distribution

  • 09421904065932 ()


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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-Q60200ER
In Commercial Distribution

  • 04540778175778 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 6.0 mm
BD-Q60200ER

  • 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-Q50200ER
In Commercial Distribution

  • 04540778175754 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 5.0 mm
BD-Q50200ER

  • 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-Q40200ER
In Commercial Distribution

  • 04540778175730 ()

  • 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; 200 mm
  • Balloon Diameter; 4.0 mm
BD-Q40200ER

  • 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-Q30200ER
In Commercial Distribution

  • 04540778175716 ()

  • 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; 200 mm
  • Balloon Diameter; 3.0 mm
BD-Q30200ER

  • 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-Q25200ER
In Commercial Distribution

  • 04540778175693 ()

  • 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; 200 mm
  • Balloon Diameter; 2.5 mm
BD-Q25200ER

  • Peripheral angioplasty balloon catheter, basic
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