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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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Pressure Monitoring Set
Edwards Lifesciences LLC
PXVPL0097
In Commercial Distribution

  • 50690103200008 ()
  • 00690103200003 ()

  • 85 in (216 cm)
PXVPL0097

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use
SAFESEAL QUATTRO 4.25 X 11 IN SELF-SEALING STERILIZATION POUCHES
AMD Medicom Inc
88045-4
In Commercial Distribution

  • 10686864047572 ()
  • 00686864047575 ()
  • 20686864047579 ()

  • 4.25 X 11 IN
88045-4

  • Sterilization packaging, single-use
SAFESEAL QUATTRO 5 1/4" X 6 1/2" SELF-SEALING STERILIZATION POUCHES
AMD Medicom Inc
88020-4
In Commercial Distribution

  • 10686864047497 ()
  • 00686864047490 ()
  • 20686864047494 ()

  • 5.25 X 6.5 IN
88020-4

  • Sterilization packaging, single-use
Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC TechNlogy
Covidien LP
P4055
In Commercial Distribution

  • 00821684044605 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 9.0 Centimeter
  • Catheter Gauge: 8 French
  • Compatible Guidewire,0.014,IN;
P4055

  • Mechanical atherectomy system catheter, peripheral
Peripheral Plaque Excision system;Distal Vessel Standard Tip
Covidien LP
P4028
In Commercial Distribution

  • 00821684043240 ()

  • Outer Diameter: 1.9 Millimeter
  • Length: 2.6 Centimeter
  • Catheter Gauge: 6 French
  • Compatible Guidewire,0.014,IN;
P4028

  • Mechanical atherectomy system catheter, peripheral
Peripheral Plaque Excision system;Small Vessel Xtra Long Tip
Covidien LP
P4033
In Commercial Distribution

  • 00821684043233 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 7.2 Centimeter
  • Catheter Gauge: 7 French
  • Compatible Guidewire,0.014,IN;
P4033

  • Mechanical atherectomy system catheter, peripheral
.018
Covidien LP
AB18W060020090
In Commercial Distribution

  • 00821684046425 ()

  • Wire Size:0.018 IN
  • Length: 90 Centimeter
AB18W060020090

  • Peripheral angioplasty balloon catheter, basic
Symmetry® Skull Tongs; w/One Spring-Loaded Point For Cervical Traction; Max Opening 6 1/4 in
SYMMETRY SURGICAL INC.
66-1025
In Commercial Distribution

  • 00887482025819 ()

  • 6.25 in Max Opening
66-1025

  • Bone lever/elevator, reusable
PS SC-035-150 TRAILBLAZER V05
EV3, INC
SC-035-150
In Commercial Distribution

  • 20763000104829 ()
  • 00763000104825 ()

  • Length: 150.0 Centimeter
  • Max. Guidewire 0.035 in
  • Catheter Gauge: 5.0 French
  • Outer Diameter: 1.04 Millimeter


  • Vascular guide-catheter, single-use
PS SC-035-135 TRAILBLAZER V05
EV3, INC
SC-035-135
In Commercial Distribution

  • 20763000104812 ()
  • 00763000104818 ()

  • Outer Diameter: 1.04 Millimeter
  • Max. Guidewire 0.035 in
  • Catheter Gauge: 5.0 French
  • Length: 135.0 Centimeter


  • Vascular guide-catheter, single-use
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