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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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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.
7.0mm x 60mm
Not in Commercial Distribution

  • M732M5IVL70600 ()

  • 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

  • Ultrasound thrombolysis system catheter, peripheral
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
ACCESS SCIENTIFIC, LLC
3Fr x 5cm
In Commercial Distribution

  • 20859821006692 ()
  • 10859821006695 ()
  • 00859821006698 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 3 French
  • Catheter Length: 5 Centimeter
96001

  • Peripheral vascular catheter
No Description
R.D.J. TOV IMPLANT LTD
6 x 13mm
In Commercial Distribution

  • 07290117800690 ()
RAGIL6L13

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
6 x 11.5mm
In Commercial Distribution

  • 07290117800683 ()
RAGIL6L11.5

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
6 x 10mm
In Commercial Distribution

  • 07290117800676 ()
RAGIL6L10

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
6 x 8mm
In Commercial Distribution

  • 07290117800669 ()
RAGIL6L8

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
5 x 13mm
In Commercial Distribution

  • 07290117800645 ()
RAGIL5L13

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
5 x 11.5mm
In Commercial Distribution

  • 07290117800638 ()
RAGIL5L11.5

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
5 x 10mm
In Commercial Distribution

  • 07290117800621 ()
RAGIL5L10

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
5 x 8mm
In Commercial Distribution

  • 07290117800614 ()
RAGIL5L8

  • Dental implant system
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