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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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Shockwave M5 - 00195451000140

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.
4.5 x 60mm
In Commercial Distribution


  • Balloon Diameter: 4.5 Millimeter
  • 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
M5IVL4560

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave M5 - 00195451000126

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.
3.5 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: 3.5 Millimeter
M5IVL3560

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter - 00195451000102

The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.5 x 12mm
In Commercial Distribution

  • 00195451000102 ()

  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Balloon Diameter: 3.5 Millimeter
  • Balloon Length: 12 Millimeter
  • Catheter Working Length: 138 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3512

  • Intravascular lithotripsy system balloon catheter, coronary

Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter - 00195451000089

The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
2.5 x 12mm
In Commercial Distribution

  • 00195451000089 ()

  • Balloon Proximal Outer Diameter (OD): 0.044 Inch
  • Balloon Diameter: 2.5 Millimeter
  • Balloon Length: 12 Millimeter
  • Catheter Working Length: 138 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL2512

  • Intravascular lithotripsy system balloon catheter, coronary

Shockwave S4 - 00195451000065

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.
3.5 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.054 Inch
  • Balloon Diameter: 3.5 Millimeter
  • Balloon Length: 40 Millimeter
  • Introducer Sheath Compatibility: 5 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
S4IVL3540

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave S4 - 00195451000058

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.
3.0 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.052 Inch
  • Balloon Diameter: 3.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Introducer Sheath Compatibility: 5 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
S4IVL3040

  • Intravascular lithotripsy system balloon catheter, peripheral

Shockwave S4 - 00195451000041

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 Humeral Short Stem System - B1132N2SN064400

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 Humeral Short Stem System - B1132N2SN063800

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 Humeral Short Stem System - B1132N2SN063200

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 Humeral Short Stem System - B1132N2SN062800

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 Humeral Short Stem System - B1132N2HE210561

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 Humeral Short Stem System - B1132N2HE210521

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 Humeral Short Stem System - B1132N2HE210500

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 Humeral Short Stem System - B1132N2HE210481

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 Humeral Short Stem System - B1132N2HE210441

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

Shoulder Innovations Humeral Short Stem System - B1132N2HE200520

Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 20mm High x 52mm Diameter R28mm Articulation.
Shoulder Innovations, Inc.
20mm x 52mm
In Commercial Distribution

  • B1132N2HE200520 ()
2N2HE20052

  • Total shoulder prosthesis

Shoulder Innovations Humeral Short Stem System - B1132N2HE190500

Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 19mm High x 50mm Diameter R27mm Articulation.
Shoulder Innovations, Inc.
19mm x 50mm
In Commercial Distribution

  • B1132N2HE190500 ()
2N2HE19050

  • Total shoulder prosthesis

PowerHeal Single Layer - 00810198031577

PowerHeal Single Layer, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198031577 ()

  • Length: 4 Inch
  • Width: 4 Inch
PSK-4040

  • Bioelectric wound dressing

PowerHeal Single Layer - 00810198031560

PowerHeal Single Layer, 2" x 2"
Vomaris Wound Care, Inc.
2" x 2"
In Commercial Distribution

  • 00810198031560 ()

  • Length: 2 Inch
  • Width: 2 Inch
PSK-0202

  • Bioelectric wound dressing
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