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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 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 - 00195451000072

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.
4.0 x 40mm
In Commercial Distribution


  • Catheter Working Length: 135 Centimeter
  • Balloon Proximal Outer Diameter (OD): 0.054 Inch
  • Balloon Diameter: 4.0 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
S4IVL4040

  • Intravascular lithotripsy system balloon catheter, peripheral

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

SIGNIA - 04063006010745

SET STYLETTO X CHARGER CN
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006010745 ()
10972018

  • Air-conduction hearing aid, behind-the-ear

Signia - 04063006010646

Silk X sDemoL Black
Ws Audiology Usa, Inc.
Silk X sDemoL
In Commercial Distribution

  • 04063006010646 ()
10970282

  • Air-conduction hearing aid, receiver-in-canal

Signia - 04063006010639

Silk X sDemoR Black (5)
Ws Audiology Usa, Inc.
Silk X sDemoR
In Commercial Distribution

  • 04063006010639 ()
10970283

  • Air-conduction hearing aid, receiver-in-canal

Signia - 04063006010622

CROS Silk X L Black
Ws Audiology Usa, Inc.
CROS Silk X
In Commercial Distribution

  • 04063006010622 ()
10970284

  • Contralateral hearing unit

Signia - 04063006010615

CROS Silk X R Black
Ws Audiology Usa, Inc.
CROS Silk X
In Commercial Distribution

  • 04063006010615 ()
10970285

  • Contralateral hearing unit

Signia - 04063006010608

CROS Silk X L Mocha
Ws Audiology Usa, Inc.
CROS Silk X
In Commercial Distribution

  • 04063006010608 ()
10970286

  • Contralateral hearing unit

Signia - 04063006010592

CROS Silk X R Mocha
Ws Audiology Usa, Inc.
CROS Silk X
In Commercial Distribution

  • 04063006010592 ()
10970287

  • Contralateral hearing unit

SIGNIA - 04063006008315

SET STYLETTO X CHARGER UK
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006008315 ()
10972016

  • Air-conduction hearing aid, behind-the-ear

SIGNIA - 04063006008308

SET STYLETTO X CHARGER EU
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006008308 ()
10972014

  • Air-conduction hearing aid, behind-the-ear

SIGNIA - 04063006008292

SET STYLETTO X CHARGER ANZ
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006008292 ()
10972017

  • Air-conduction hearing aid, behind-the-ear

SIGNIA - 04063006004843

ACC. STYLETTO X CHARGER
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006004843 ()
10968447

  • Noninvasive device battery charger

Hansol Medical Co. - 08809118710953

No Description
Hansol Medical Co.
0.20mm x 75mm
In Commercial Distribution

  • 08809118710953 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710939

No Description
Hansol Medical Co.
0.18mm x 8mm
In Commercial Distribution

  • 08809118710939 ()
  • 18809118710936 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710915

No Description
Hansol Medical Co.
0.40mm x 120mm
In Commercial Distribution

  • 08809118710915 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710892

No Description
Hansol Medical Co.
0.40mm x 105mm
In Commercial Distribution

  • 08809118710892 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710878

No Description
Hansol Medical Co.
0.40mm x 90mm
In Commercial Distribution

  • 08809118710878 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710854

No Description
Hansol Medical Co.
0.40mm x 75mm
In Commercial Distribution

  • 08809118710854 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710830

No Description
Hansol Medical Co.
0.40mm x 60mm
In Commercial Distribution

  • 08809118710830 ()
  • 18809118710837 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710816

No Description
Hansol Medical Co.
0.40mm x 50mm
In Commercial Distribution

  • 08809118710816 ()
  • 18809118710813 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710793

No Description
Hansol Medical Co.
0.40mm x 40mm
In Commercial Distribution

  • 08809118710793 ()
  • 18809118710790 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710779

No Description
Hansol Medical Co.
0.40mm x 30mm
In Commercial Distribution

  • 08809118710779 ()
  • 18809118710776 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710755

No Description
Hansol Medical Co.
0.40mm x 15mm
In Commercial Distribution

  • 08809118710755 ()
  • 18809118710752 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710731

No Description
Hansol Medical Co.
0.35mm x 120mm
In Commercial Distribution

  • 08809118710731 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710717

No Description
Hansol Medical Co.
0.35mm x 105mm
In Commercial Distribution

  • 08809118710717 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710694

No Description
Hansol Medical Co.
0.35mm x 90mm
In Commercial Distribution

  • 08809118710694 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710670

No Description
Hansol Medical Co.
0.35mm x 75mm
In Commercial Distribution

  • 08809118710670 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710656

No Description
Hansol Medical Co.
0.35mm x 60mm
In Commercial Distribution

  • 08809118710656 ()
  • 18809118710653 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710632

No Description
Hansol Medical Co.
0.35mm x 50mm
In Commercial Distribution

  • 08809118710632 ()
  • 18809118710639 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710618

No Description
Hansol Medical Co.
0.35mm x 40mm
In Commercial Distribution

  • 08809118710618 ()
  • 18809118710615 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710595

No Description
Hansol Medical Co.
0.35mm x 30mm
In Commercial Distribution

  • 08809118710595 ()
  • 18809118710592 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710397

No Description
Hansol Medical Co.
0.30mm x 15mm
In Commercial Distribution

  • 08809118710397 ()
  • 18809118710394 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710571

No Description
Hansol Medical Co.
0.35mm x 15mm
In Commercial Distribution

  • 08809118710571 ()
  • 18809118710578 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710557

No Description
Hansol Medical Co.
0.30mm x 120mm
In Commercial Distribution

  • 08809118710557 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710533

No Description
Hansol Medical Co.
0.30mm x 105mm
In Commercial Distribution

  • 08809118710533 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710519

No Description
Hansol Medical Co.
0.30mm x 90mm
In Commercial Distribution

  • 08809118710519 ()


  • Acupuncture needle, single-use
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