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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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ViperCross Support Catheter, 018", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-090
In Commercial Distribution

  • 10850026568155 ()

  • Guidewire Compability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 90cm
  • Tip Shape: Straight
7-10093-02

  • Vascular microcatheter
ViperCross Support Catheter, 018", 65cm Straight
Cardiovascular Systems, Inc.
P1VC-018STR-065
In Commercial Distribution

  • 10850026568148 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 65cm
  • Tip Shape: Straight
7-10093-01

  • Vascular microcatheter
ViperCross Support Catheter, 014", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-150
In Commercial Distribution

  • 10850026568131 ()

  • Guidewire Compability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10092-02

  • Vascular microcatheter
ViperCross Support Catheter, 014", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-135
In Commercial Distribution

  • 10850026568124 ()

  • Guidewire Compatability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10092-01

  • Vascular microcatheter
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
STEALTH, 2.00 MAX CROWN, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-MAX-200
In Commercial Distribution

  • 10850026568711 ()

  • Crown Diameter: 2.00 mm
7-10059-46

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK EXCHANGEABLE SYSTEM, 2.00 MAX CROWN, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–EX-200MAX145
In Commercial Distribution

  • 10850026568476 ()

  • Crown Diameter: 2.00 mm
7-10030-13

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK EXCHANGEABLE CARTRIDGE, 2.00 MAX CROWN, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-CART-200MAX145
In Commercial Distribution

  • 10850026568469 ()

  • Crown Diameter: 2.00 mm
7-10031-13

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MAX CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200MAX145
In Commercial Distribution

  • 10850026568445 ()

  • Crown Diameter: 2.00 mm
7-10057-10

  • Mechanical atherectomy system catheter, peripheral
ViperCross Support Catheter, 035", 150cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-150
In Commercial Distribution

  • 10850026568254 ()

  • Guidewire Compatability 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 150 cm
  • Tip Shape: Angled
7-10094-08

  • Vascular microcatheter
ViperCross Support Catheter, 035", 135cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-135
In Commercial Distribution

  • 10850026568247 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 135cm
  • Tip Shape: Angled
7-10094-07

  • Vascular microcatheter
ViperCross Support Catheter, 035", 90cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-090
In Commercial Distribution

  • 10850026568230 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 90cm
  • Tip Shape: Angled
7-10094-06

  • Vascular microcatheter
ViperCross Support Catheter, 035", 65cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-065
In Commercial Distribution

  • 10850026568223 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 65cm
  • Tip Shape: Angled
7-10094-05

  • Vascular microcatheter
ViperCross Support Catheter, 035", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-150
In Commercial Distribution

  • 10850026568216 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10094-04

  • Vascular microcatheter
ViperCross Support Catheter, 035", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-135
In Commercial Distribution

  • 10850026568209 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10094-03

  • Vascular microcatheter
ViperCross Support Catheter, 035", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-090
In Commercial Distribution

  • 10850026568193 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 90cm
  • Tip Shape: Straight
7-10094-02

  • Vascular microcatheter
ViperCross Support Catheter, 035", 65cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-065
In Commercial Distribution

  • 10850026568186 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 65cm
  • Tip Shape: Straight
7-10094-01

  • Vascular microcatheter
ViperCross Support Catheter, 018", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-150
In Commercial Distribution

  • 10850026568179 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10093-04

  • Vascular microcatheter
ViperCross Support Catheter, 018", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-135
In Commercial Distribution

  • 10850026568162 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10093-03

  • Vascular microcatheter
Wirion Embolic Protection System
Cardiovascular Systems, Inc.
WRN-D6
In Commercial Distribution

  • 10850000491882 ()

  • Deployed Filter Unit Length 22.5 mm
  • Deployed Filter Diameter 3.5-6.0 mm
  • Distal tip to strain relief (usable length) - delivery 144 cm
  • Rapid Exchange (RX) length - delivery 38 cm
  • Maximum catheter diameter - delivery 1.14 mm
  • Distal tip to strain relief (usable length) - retrieval 145 cm
  • Rapid Exchange (RX) length - retrieval 31 cm
  • Maximum catheter diameter - retrieval 1.67 mm
7-10078-01

  • Embolic protection filtering guidewire
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
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 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
Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
Cardiovascular Systems, Inc.
DBP-175SOLID180
In Commercial Distribution

  • 10850000491233 ()

  • 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
7-10057-07

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-150SOLID200
In Commercial Distribution

  • 10850000491226 ()

  • 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: 1.50 mm
7-10057-06

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-125SOLID200
In Commercial Distribution

  • 10850000491219 ()

  • 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: 1.25 mm
7-10057-05

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200SOLID145
In Commercial Distribution

  • 10850000491202 ()

  • Intro Sheath: 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
7-10057-04

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10850000491196 ()

  • 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
7-10057-03

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10850000491189 ()

  • 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 size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 7 mm
  • Crown diameter: 1.25 mm
7-10057-02

  • Mechanical atherectomy system catheter, peripheral
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