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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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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

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 - 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 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

STERIZONE® VP4 Test Pack Kit - 00690455440201

Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor
TSO3 Inc
44020
In Commercial Distribution

  • 00690455440201 ()
44020

  • Biological sterilization indicator

125-280 Solution™ for STERIZONE VP4 Sterilizer - 00690455440102

The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
TSO3 Inc
44010
In Commercial Distribution

  • 00690455045604 ()
  • 00690455440102 ()
44010

  • Hydrogen peroxide device sterilant
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