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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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STEALTH PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10850000491332 ()

  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • Crown Type Classic
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 15 mm
  • Crown Diameter 1.50 mm
7-10059-08

  • Mechanical atherectomy system catheter, peripheral
STEALTH Peripheral, Radial Access OAD, 1.75mm, 30mm, 180cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-175
In Commercial Distribution

  • 10850000491325 ()

  • Intro Sheath 5 Fr
  • Max OD 0.069 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 180 cm
  • Nose Length 30 mm
  • Crown Diameter 1.75 mm
7-10059-07

  • Mechanical atherectomy system catheter, peripheral
STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-150
In Commercial Distribution

  • 10850000491318 ()

  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 200 cm
  • Nose Length 10 mm
  • Crown Diameter 1.5 mm
7-10059-06

  • Mechanical atherectomy system catheter, peripheral
STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-125
In Commercial Distribution

  • 10850000491301 ()

  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 200 cm
  • Nose Length 10 mm
  • Crown Diameter 1.5 mm
7-10059-05

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10850000491295 ()

  • Intro Shealth 6 Fr
  • Max OD 0.079 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
7-10059-04

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10850000491288 ()

  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10059-03

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10850000491271 ()

  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
7-10059-02

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-MICRO
In Commercial Distribution

  • 10850000491264 ()

  • Crown Diameter 1.25 mm
  • High Speed 140 krpm
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • Crown Type Micro
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
7-10059-01

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200CLASS145
In Commercial Distribution

  • 10850000491257 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 20 mm
  • Crown diameter: 2.00 mm
7-10057-09

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150CLASS145
In Commercial Distribution

  • 10850000491240 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 15 mm
  • Crown diameter: 1.50 mm
7-10057-08

  • Mechanical atherectomy system catheter, peripheral
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