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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Stealth, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-150
In Commercial Distribution

  • 10852528005763 ()

  • Crown Diameter 1.5 mm
7-10058-02

  • Mechanical atherectomy system catheter, peripheral
Stealth, Radial Access OAD, 1.25mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-125
In Commercial Distribution

  • 10852528005756 ()

  • Crown diameter 1.25mm
7-10058-01

  • Mechanical atherectomy system catheter, peripheral
ViperWire, Advance, Flex Tip, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX18
In Commercial Distribution

  • 30852528005743 ()
  • 10852528005749 ()

  • Max Tip Diameter 0.018 inches
7-10041-02

  • Peripheral vascular guidewire, manual
VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX18
In Commercial Distribution

  • 30852528005729 ()
  • 10852528005725 ()

  • Max Tip Diameter 0.018 inches
7-10041-04

  • Peripheral vascular guidewire, manual
200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-1
In Commercial Distribution

  • 10852528005695 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-02

  • Vascular guide-catheter, single-use
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-175SOL180
In Commercial Distribution

  • 10852528005008 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 180cm
  • Nose Length: 30mm
  • Crown Diameter: 1.75mm
7-10031-09

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568100 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft Length, 135cm
  • Guidewire Size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495
  • Intro Sheath, 6
7-10060-10

  • Mechanical atherectomy system, coronary, line-powered
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568087 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft length, 135cm
  • Guidewire size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495 inches
  • Intro Sheath, 6Fr
7-10060-09

  • Mechanical atherectomy system, coronary, line-powered
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850000491363 ()

  • Crown Diameter: 1.25mm
  • nose length: 5mm
  • shaft length: 135cm
  • guidewire size OD: 0.012 inches
  • low speed: 80krpm
  • high speed: 120krpm
  • Crown Type: Classic
  • Max OD: 0.052 inches
  • Intro Sheath: 6Fr
7-10060-02

  • Mechanical atherectomy system, coronary, line-powered
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850000491356 ()

  • Crown diameter: 1.25mm
  • nose length: 5mm
  • shaft length: 135cm
  • guidewire size OD: 0.012 inches
  • low speed: 80 krpm
  • high speed: 120 krpm
  • Max OD: 0.0495 inches
  • Intro Sheath: 6 Fr
  • Crown Type: Classic
7-10060-01

  • Mechanical atherectomy system, coronary, line-powered
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