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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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Diamondback Coronary - 10850000491363

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 - 10850000491356

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

Stealth - 10850000491349

STEALTH PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10850000491349 ()

  • Medium Speed 90 krpm
  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • Crown Type Classic
  • High Speed 140 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 20 mm
  • Crown Diameter 2.00 mm
7-10059-09

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491332

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 - 10850000491325

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 - 10850000491318

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 - 10850000491301

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 - 10850000491295

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 - 10850000491288

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 - 10850000491271

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
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