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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 - 10850026568162

ViperCross Support Catheter, 018", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-135
Not in Commercial Distribution

  • 10850026568162 ()

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

  • Vascular microcatheter

ViperCross - 10850026568155

ViperCross Support Catheter, 018", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-090
Not 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 - 10850026568148

ViperCross Support Catheter, 018", 65cm Straight
Cardiovascular Systems, Inc.
P1VC-018STR-065
Not 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 - 10850026568131

ViperCross Support Catheter, 014", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-150
Not 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 - 10850026568124

ViperCross Support Catheter, 014", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-135
Not 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 - 10850026568100

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 - 10850026568087

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

Shepherd - 10850026568605

0.018" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-30006
In Commercial Distribution

  • 30850026568609 ()
  • 10850026568605 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydorphilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568582

0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-30006
In Commercial Distribution

  • 30850026568586 ()
  • 10850026568582 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568568

0.018" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-30004
In Commercial Distribution

  • 30850026568562 ()
  • 10850026568568 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568544

0.014" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-30004
In Commercial Distribution

  • 10850026568544 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straighht
  • Tip Design Polymer Jacket
7-10096-02

  • Peripheral vascular guidewire, manual

Diamondback Peripheral - 10852528005992

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL200
In Commercial Distribution

  • 10852528005992 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.50mm
7-10031-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005985

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL200
In Commercial Distribution

  • 10852528005985 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.25mm
7-10031-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005978

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL75
In Commercial Distribution

  • 10852528005978 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75cm
  • Nose Length: 7mm
  • Crown diameter: 1.25mm
7-10031-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005909

Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-150CLA145
In Commercial Distribution

  • 10852528005909 ()

  • 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: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 15 mm
  • Crown Diameter: 1.50 mm
7-10030-10

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005893

Diamondback Peripheral, Exchangeable Series, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-175SOL180
In Commercial Distribution

  • 10852528005893 ()

  • Intro Sheath: 6 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
7-10030-09

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005886

Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-150SOL200
In Commercial Distribution

  • 10852528005886 ()

  • 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
7-10030-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005879

Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL200
In Commercial Distribution

  • 10852528005879 ()

  • Intro Sheath: 4 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
7-10030-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005862

Diamondback Peripheral, Exchangeable Series, 1.25 Solid 75 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL75
In Commercial Distribution

  • 10852528005862 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005855

Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 75 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125MIC75
In Commercial Distribution

  • 10852528005855 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-05

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005848

Diamondback Peripheral, Exchangeable Series, 2.00 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-200SOL145
In Commercial Distribution

  • 10852528005848 ()

  • 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
7-10030-04

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005831

Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-150SOL145
In Commercial Distribution

  • 10852528005831 ()

  • 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: 145 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10030-03

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005824

Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL145
In Commercial Distribution

  • 10852528005824 ()

  • Guidewire: 0.014 inches
  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-02

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005817

Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125MIC145
In Commercial Distribution

  • 10852528005817 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 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
7-10030-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Coronary - 10852528005787

CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10852528005787 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.057 inches
  • Crown Type: Classic
  • High speed: 120 krpm
  • low speed: 80 krpm
  • guidewire size OD 0.012 inches
  • shaft length: 135 cm
  • nose length: 5 mm
  • Crown diameter: 1.25 mm
70058-13

  • Mechanical atherectomy system, coronary, line-powered

Stealth - 10852528005770

Stealth, Radial Access OAD, 1.75mm, 30mm, 180cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-175
In Commercial Distribution

  • 10852528005770 ()

  • Crown Diameter 1.75 mm
7-10058-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005763

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 - 10852528005756

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

Extended Length ViperWire Advance - 10852528005749

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

Extended Length ViperWire Advance - 10852528005732

ViperWire, Advance, , Flex Tip, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX14
In Commercial Distribution

  • 30852528005736 ()
  • 10852528005732 ()

  • Max Tip Diameter 0.014 inches
7-10041-01

  • Peripheral vascular guidewire, manual
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