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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 - 10852528005947

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

  • 10852528005947 ()

  • 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
7-10031-03

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005930

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

  • 10852528005930 ()

  • 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
7-10031-02

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005923

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

  • 10852528005923 ()

  • 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
7-10031-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005916

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

  • 10852528005916 ()

  • 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: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 20 mm
  • Crown Diameter: 2.00 mm
7-10030-11

  • Mechanical atherectomy system catheter, peripheral

Diamondback Coronary - 10852528005800

SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005800 ()
7-10037-07

  • Atherectomy system saline/lubricant pump

Stealth - 10852528005343

STEALTH, SOLID, 2.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-225
In Commercial Distribution

  • 10852528005343 ()

  • 7 Fr Intro sheath
  • 0.089 inches Max OD
  • Solid Crown type
  • 120 krpm High speed
  • 90 krpm Medium speed
  • 60 krpm Low speed
  • 0.014 inches Guidewire size OD
  • 145 cm Shaft Length
  • 30 mm Nose length
  • 2.25 mm Crown diameter
70056-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005275

DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–200SOLID145
In Commercial Distribution

  • 10852528005275 ()

  • Crown Type, Solid
  • Intro Sheath 6Fr
  • Max OD 0.079 inches
  • High speed 120krpm
  • Medium speed 90krpm
  • Low speed 60krpm
  • Guidewire 0.014 inches
  • Shaft length 145cm
  • Nose length 30mm
  • Crown diameter 2.00mm
DBP–200SOLID145

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005190

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
Not in Commercial Distribution

  • 10852528005190 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 140 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
DBP-125MICRO145

  • Mechanical atherectomy system catheter, peripheral

Diamondback Coronary - 10852528005183

Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FLP
In Commercial Distribution

  • 30852528005187 ()
  • 10852528005183 ()

  • Length; 325cm
  • Max Shaft Diameter; 0.012 inches
  • Max Tip Diameter; 0.014 inches
72010-01

  • Cardiac/peripheral vascular guidewire, single-use

Diamondback Coronary - 10852528005176

CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
Cardiovascular Systems, Inc.
DBEC-150
In Commercial Distribution

  • 10852528005176 ()

  • Intro Sheath; 6Fr
  • Max OD; 0.061 inches
  • High speed; 120krpm
  • Low speed; 80krpm
  • Guidewire size OD; 0.012 inches
  • Shaft length; 135cm
  • Nose length; 10mm
  • Crown diameter; 1.5mm
  • Crown Type, Classic
70058-03

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10852528005169

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

  • 10852528005169 ()

  • Intro Sheath; 6 french
  • Max OD; 0.057 inches
  • High speed; 120 krpm
  • low speed; 80 krpm
  • Guidewire size OD; 0.012 inches
  • Shaft Length; 135 cm
  • Nose Length; 5mm
  • Crown Size; 1.25 mm
  • Crown Type, Classic
70058-02

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10852528005138

SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005138 ()
70057-03

  • Atherectomy system saline/lubricant pump

Viperslide - 10852528005121

VIPERSLIDE, 100ML BAG, 10 PK
Cardiovascular Systems, Inc.
VPR-SLD2
In Commercial Distribution

  • 30852528005125 ()
  • 10852528005121 ()
72031-01

  • Atherectomy system lubricant

ViperTrack - 10852528005114

VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPRTRKMM20
In Commercial Distribution

  • 30852528005118 ()
  • 10852528005114 ()

  • Length: 500 Millimeter
72029-01

  • X-ray film ruler

ViperTrack - 10852528005107

VIPERTRACK, 50 PACK
Cardiovascular Systems, Inc.
VPR-TRK
In Commercial Distribution

  • 30852528005101 ()
  • 10852528005107 ()

  • Length: 30 Centimeter
72014-02

  • X-ray film ruler

ViperTrack - 10852528005091

VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPR-TRK 20
In Commercial Distribution

  • 10852528005091 ()
  • 30852528005095 ()

  • Length: 30 Centimeter
72014-01

  • X-ray film ruler

ViperWire, Advance - 10852528005084

VIPERWIRE, ADVANCE PERIPHERAL, .017" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-17
In Commercial Distribution

  • 30852528005088 ()
  • 10852528005084 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.017 inches
72023-02

  • Peripheral vascular guidewire, manual

ViperWire, Advance - 10852528005077

VIPERWIRE, ADVANCE PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-14
In Commercial Distribution

  • 30852528005071 ()
  • 10852528005077 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
72023-01

  • Peripheral vascular guidewire, manual

Stealth - 10852528005060

STEALTH, SOLID MICRO, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125S
In Commercial Distribution

  • 10852528005060 ()

  • Crown Type, Solid Micro
  • Intro Sheath 6Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown Diameter 1.25 mm
70056-11

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005053

STEALTH, SOLID, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10852528005053 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Solid
70056-06

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005046

STEALTH, SOLID, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10852528005046 ()

  • Intro Sheath 6 Fr
  • max OD 0.070 inches
  • 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
  • Crown Type, Solid
70056-04

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005039

STEALTH, SOLID, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10852528005039 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • 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 1.25 mm
  • Crown Type, Solid
70056-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005022

STEALTH, CLASSIC, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10852528005022 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • 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
  • Crown Type, Classic
70056-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005015

STEALTH, CLASSIC, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • 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
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral

SurePass CTR NS Blade - 00860011634836

Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable

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

STERIZONE® VP4 Sterilizer - 00690455440003

The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States
TSO3 Inc
44000-R
In Commercial Distribution

  • 00690455440003 ()
44000-R

  • Ozone/hydrogen peroxide sterilizer

STERIZONE® CI+ Chemical indicator - 00690455438109

The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer.
TSO3 Inc
43810-1
In Commercial Distribution

  • 00690455438109 ()
  • 00690455438116 ()
43810-1

  • Chemical/physical sterilization process indicator

STERIZONE® BI+ Self-contained Biological Indicator - 00690455426021

The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
TSO3 Inc
42602-1
In Commercial Distribution

  • 00690455426021 ()
  • 00690455750218 ()
42602-1

  • Biological sterilization indicator
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