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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 Peripheral - 10850000491189

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

Diamondback Peripheral - 10850000491172

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10850000491172 ()

  • 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
7-10057-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491035

Diamondback Peripheral, Exchangeable Series, Handle Only
Cardiovascular Systems, Inc.
DBP-EX-HANDLE
In Commercial Distribution

  • 10850000491035 ()
7-10032-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491028

Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200CLA145
In Commercial Distribution

  • 10850000491028 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 20mm
  • Crown Diameter: 2.00mm
7-10031-11

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491011

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150CLA145
In Commercial Distribution

  • 10850000491011 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 15mm
  • Crown Diameter: 1.50mm
7-10031-10

  • Mechanical atherectomy system catheter, peripheral

STEALTH - 10850026568711

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

Shepherd - 10850026568681

0.018" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-30030
In Commercial Distribution

  • 30850026568685 ()
  • 10850026568681 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568674

0.018" Shepherd ES Guidewire - straight 195 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-19530
In Commercial Distribution

  • 30850026568678 ()
  • 10850026568674 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568667

0.014" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-30030
In Commercial Distribution

  • 30850026568661 ()
  • 10850026568667 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Hydrophilic Coating
  • Tip Design Polymer Jacket
7-10097-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568650

0.014" Shepherd ES Guidewire - straight 195 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-19530
In Commercial Distribution

  • 30850026568654 ()
  • 10850026568650 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-05

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568643

0.018" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-30012
In Commercial Distribution

  • 30850026568647 ()
  • 10850026568643 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568636

0.018" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-19512
In Commercial Distribution

  • 30850026568630 ()
  • 10850026568636 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568629

0.014" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-30012
In Commercial Distribution

  • 30850026568623 ()
  • 10850026568629 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-02

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568612

0.014" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-19512
In Commercial Distribution

  • 30850026568616 ()
  • 10850026568612 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-01

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568599

0.018" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-19506
In Commercial Distribution

  • 30850026568593 ()
  • 10850026568599 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrdophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568575

0.014" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-19506
In Commercial Distribution

  • 30850026568579 ()
  • 10850026568575 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-05

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568551

0.018" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-19504
In Commercial Distribution

  • 30850026568555 ()
  • 10850026568551 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydorphilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568537

0.014" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-19504
In Commercial Distribution

  • 30850026568531 ()
  • 10850026568537 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Inch
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-01

  • Peripheral vascular guidewire, manual

DIAMONDBACK - 10850026568476

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 - 10850026568469

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 - 10850026568445

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 - 10850026568254

ViperCross Support Catheter, 035", 150cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-150
Not 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 - 10850026568247

ViperCross Support Catheter, 035", 135cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-135
Not 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 - 10850026568230

ViperCross Support Catheter, 035", 90cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-090
Not 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 - 10850026568223

ViperCross Support Catheter, 035", 65cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-065
Not 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 - 10850026568216

ViperCross Support Catheter, 035", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-150
Not 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 - 10850026568209

ViperCross Support Catheter, 035", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-135
Not 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 - 10850026568193

ViperCross Support Catheter, 035", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-090
Not 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 - 10850026568186

ViperCross Support Catheter, 035", 65cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-065
Not 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 - 10850026568179

ViperCross Support Catheter, 018", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-150
Not in Commercial Distribution

  • 10850026568179 ()

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

  • Vascular microcatheter
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