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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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No Description
R.D.J. TOV IMPLANT LTD
3.5 x 11.5mm
In Commercial Distribution

  • 07290117800027 ()
MAER3.5L11.5

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

  • 07290117800010 ()
MAER3.5L10

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

  • 07290117800003 ()
MAER3.5L8

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 16mm
In Commercial Distribution

  • D169BPIH4216 ()
BITP4216IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 14mm
In Commercial Distribution

  • D169BPIH4214 ()
BITP4214IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 12mm
In Commercial Distribution

  • D169BPIH4212 ()
BITP4212IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 10mm
In Commercial Distribution

  • D169BPIH4210 ()
BITP4210IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 16mm
In Commercial Distribution

  • D169BPIH3516 ()
BITP3516IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 14mm
In Commercial Distribution

  • D169BPIH3514 ()
BITP3514IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 12mm
In Commercial Distribution

  • D169BPIH3512 ()
BITP3512IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 10mm
In Commercial Distribution

  • D169BPIH3510 ()
BITP3510IH

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 16mm
In Commercial Distribution

  • D169BPCC4216 ()
BITP4216CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 14mm
In Commercial Distribution

  • D169BPCC4214 ()
BITP4214CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 12mm
In Commercial Distribution

  • D169BPCC4212 ()
BITP4212CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
4.2 x 10mm
In Commercial Distribution

  • D169BPCC4210 ()
BITP4210CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 16mm
In Commercial Distribution

  • D169BPCC3516 ()
BITP3516CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 14mm
In Commercial Distribution

  • D169BPCC3514 ()
BITP3514CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 12mm
In Commercial Distribution

  • D169BPCC3512 ()
BITP3512CC

  • Dental implant system
No Description
QUICKDENT DEVICES PRIVATE LIMITED
3.5 x 10mm
In Commercial Distribution

  • D169BPCC3510 ()
BITP3510CC

  • Dental implant system
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
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