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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 S4 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 distal catheter and balloon are hydrophilic coated to increase lubricity. 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.
2.5 x 40mm
In Commercial Distribution


  • Balloon Rated Burst Pressure: 10 Atmosphere
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Guidewire Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 5 French
  • Balloon Length: 40 Millimeter
  • Balloon Diameter: 2.5 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.052 Inch
  • Catheter Working Length: 135 Centimeter
S4IVL2540

  • Intravascular lithotripsy system balloon catheter, peripheral
Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 44mm x 6mm.
Shoulder Innovations, Inc.
44mm x 6mm
In Commercial Distribution

  • B1132N2SN064400 ()
2N2SN06440

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 38mm x 6mm.
Shoulder Innovations, Inc.
38mm x 6mm
In Commercial Distribution

  • B1132N2SN063800 ()
2N2SN06380

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 32 mm x 6mm.
Shoulder Innovations, Inc.
32mm x 6mm
In Commercial Distribution

  • B1132N2SN063200 ()
2N2SN06320

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 28mm x 6mm.
Shoulder Innovations, Inc.
28mm x 6mm
In Commercial Distribution

  • B1132N2SN062800 ()
2N2SN06280

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 56mm Diameter R31mm Articulation.
Shoulder Innovations, Inc.
21mm x 56mm
In Commercial Distribution

  • B1132N2HE210561 ()
2N12HE21056

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 52mm Diameter R28mm Articulation.
Shoulder Innovations, Inc.
21mm x 52mm
In Commercial Distribution

  • B1132N2HE210521 ()
2N2HE21052

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 50mm Diameter R26mm Articulation.
Shoulder Innovations, Inc.
21mm x 50mm
In Commercial Distribution

  • B1132N2HE210500 ()
2N2HE21050

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 48mm Diameter R25mm Articulation.
Shoulder Innovations, Inc.
21mm x 48mm
In Commercial Distribution

  • B1132N2HE210481 ()
2N2HE21048

  • Total shoulder prosthesis
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 44mm Diameter R22mm Articulation.
Shoulder Innovations, Inc.
21mm x 44mm
In Commercial Distribution

  • B1132N2HE210441 ()
2N12HE21044

  • Total shoulder prosthesis
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