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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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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
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