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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 - 10850000491226

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 - 10850000491219

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 - 10850000491202

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 - 10850000491196

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 - 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

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
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
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
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
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
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
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
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
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
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 - 10850026568162

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

ViperCross - 10850026568155

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 - 10850026568148

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 - 10850026568131

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 - 10850026568124

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 - 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

Diamondback Coronary - 10850026568698

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered

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

ViperWire Advance FlexTip - 10852528005725

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX18
In Commercial Distribution

  • 30852528005729 ()
  • 10852528005725 ()

  • Max Tip Diameter 0.018 inches
7-10041-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005626

4gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-014
Not in Commercial Distribution

  • 10852528005626 ()
  • 30852528005620 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 300cm
7-10049-02

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005619

4gram tip, short taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-014
Not in Commercial Distribution

  • 30852528005613 ()
  • 10852528005619 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 195cm
7-10049-01

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005602

30gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-018
Not in Commercial Distribution

  • 30852528005606 ()
  • 10852528005602 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 300cm
7-10050-08

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005596

30gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
30G-195-018
Not in Commercial Distribution

  • 30852528005590 ()
  • 10852528005596 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 195cm
7-10050-07

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005589

30gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-014
Not in Commercial Distribution

  • 30852528005583 ()
  • 10852528005589 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 30 grams; Length: 300cm
7-10050-06

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005572

30gram tip, short taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
30G-195-014
Not in Commercial Distribution

  • 30852528005576 ()
  • 10852528005572 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 30 grams; Length: 195cm
7-10050-05

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005565

12gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
12G-300-018
Not in Commercial Distribution

  • 30852528005569 ()
  • 10852528005565 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 12 grams; Length: 300cm
7-10050-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005558

12gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
12G-195-018
Not in Commercial Distribution

  • 30852528005552 ()
  • 10852528005558 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 12 grams; Length: 195cm
7-10050-03

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005541

12gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
12G-300-014
Not in Commercial Distribution

  • 30852528005545 ()
  • 10852528005541 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 12 grams; Length: 300cm
7-10050-02

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005534

12 gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
12G-195-014
Not in Commercial Distribution

  • 30852528005538 ()
  • 10852528005534 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 12 grams; Length: 195cm
7-10050-01

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005527

6 gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-018
Not in Commercial Distribution

  • 30852528005521 ()
  • 10852528005527 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 300cm
7-10049-08

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005510

6gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-018
Not in Commercial Distribution

  • 30852528005514 ()
  • 10852528005510 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 195cm
7-10049-07

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005503

6gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-014
Not in Commercial Distribution

  • 30852528005507 ()
  • 10852528005503 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 300cm
7-10049-06

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005497

6gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-014
Not in Commercial Distribution

  • 30852528005491 ()
  • 10852528005497 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 195cm
7-10049-05

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005480

4gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-018
Not in Commercial Distribution

  • 30852528005484 ()
  • 10852528005480 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 300cm
7-10049-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005473

4gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-018
Not in Commercial Distribution

  • 10852528005473 ()
  • 30852528005477 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 195cm
7-10049-03

  • Peripheral vascular guidewire, manual

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
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