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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 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.
4.0 x 12mm
In Commercial Distribution

  • 00195451000119 ()

  • Balloon Proximal Outer Diameter (OD): 0.047 Inch
  • Balloon Diameter: 4.0 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
C2IVL4012

  • Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2+ Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation 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+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, 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.
3.0x12mm
In Commercial Distribution

  • 00195451000010 ()

  • Balloon Length: 12 Centimeter
  • Balloon Diameter: 3.0 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Length: 138 Centimeter
  • Guidewire Compatibility: 5 French
C2PIVL3012

  • Intravascular lithotripsy system balloon catheter, coronary
Ligature Sleeve
Oscor Inc.
664760-303
In Commercial Distribution

  • 20885672008349 ()
  • 00885672008345 ()

  • Lumen/Inner Diameter: 2.1 Millimeter
LS21-10

  • Endocardial defibrillation lead
No Description
Resolution Bioscience, Inc.
500029
Not in Commercial Distribution

  • 00850059806005 ()


  • Venous blood collection kit IVD
Genesys HTA 115V Control Unit (Refurbished)
Minerva Surgical, Inc.
M00658001R0
In Commercial Distribution

M00658001R0

  • Circulating-fluid endometrial-ablation control unit
Genesys HTA 115V Control Unit
Minerva Surgical, Inc.
M006580010
In Commercial Distribution

M006580010

  • Circulating-fluid endometrial-ablation control unit
IMD AMSG3-E Kit
Avertix Medical Inc.
0212-2100-001#P16
In Commercial Distribution

  • 00850012625001 ()
0212-2100-001#P16

  • Implantable cardiac monitor
VS-402 VENASEAL CLOSURE SYSTEM X5
MEDTRONIC, INC.
VS-402
Not in Commercial Distribution

  • 20643169986262 ()
  • 00643169986268 ()


  • Varicose vein adhesive-treatment kit
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution

  • 0193-6262-01 ()
  • 00301936262013 ()
85092979

  • Glucose monitoring system IVD, home-use
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