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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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No Description
L&R USA INC.
5cm x 5cm
In Commercial Distribution

  • 20744084000641 ()
  • 10744084000644 ()
  • 00744084000647 ()
32755

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X URS
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, analogue
The SEDECAL X (URS) Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X (URS)
In Commercial Distribution

  • 08436046000933 ()


  • Stationary basic diagnostic x-ray system, analogue
No Description
SORIN GROUP ITALIA SRL
SEQUESTRATION SET X
In Commercial Distribution

  • 38033178114333 ()
  • 18033178114339 ()
  • 08033178114332 ()


  • Blood donor set, double-pack
No Description
SORIN GROUP ITALIA SRL
SEQUESTRATION SET X
In Commercial Distribution

  • 38033178110526 ()
  • 18033178110522 ()
  • 08033178110525 ()


  • Autotransfusion system blood component processing set
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
7.0 x 60mm
In Commercial Distribution


  • Catheter Working Length: 110 Centimeter
  • Balloon Diameter: 7.0 Millimeter
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Introducer Sheath Compatibility: 7 French
  • Balloon Proximal Outer Diameter (OD): 0.072 Inch
  • Guidewire Diameter: 0.014 Inch
M5IVL7060

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
6.5 x 60mm
In Commercial Distribution


  • Catheter Working Length: 110 Centimeter
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Balloon Proximal Outer Diameter (OD): 0.072 Inch
  • Introducer Sheath Compatibility: 7 French
  • Balloon Diameter: 6.5 Millimeter
M5IVL6560

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
6.0 x 60mm
In Commercial Distribution


  • Balloon Diameter: 6.0 Millimeter
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
M5IVL6060

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
5.5 x 60mm
In Commercial Distribution


  • Introducer Sheath Compatibility: 6 French
  • Catheter Working Length: 110 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Balloon Length: 60 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Balloon Diameter: 5.5 Millimeter
M5IVL5560

  • Intravascular lithotripsy system balloon catheter, peripheral
The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Shockwave Medical, Inc.
5.0 x 60mm
In Commercial Distribution


  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Length: 60 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.064 Inch
  • Catheter Working Length: 110 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Balloon Diameter: 5.0 Millimeter
M5IVL5060

  • Intravascular lithotripsy system balloon catheter, peripheral
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