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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 Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-125
In Commercial Distribution

  • 10850000491301 ()

  • 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 1.5 mm
7-10059-05

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10850000491295 ()

  • Intro Shealth 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
7-10059-04

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10850000491288 ()

  • 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
7-10059-03

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10850000491271 ()

  • 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
7-10059-02

  • Mechanical atherectomy system catheter, peripheral
STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-MICRO
In Commercial Distribution

  • 10850000491264 ()

  • Crown Diameter 1.25 mm
  • High Speed 140 krpm
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • Crown Type Micro
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
7-10059-01

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200CLASS145
In Commercial Distribution

  • 10850000491257 ()

  • 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 size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 20 mm
  • Crown diameter: 2.00 mm
7-10057-09

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150CLASS145
In Commercial Distribution

  • 10850000491240 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • 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
7-10057-08

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
Cardiovascular Systems, Inc.
DBP-175SOLID180
In Commercial Distribution

  • 10850000491233 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 180 cm
  • nose length: 30 mm
  • Crown diameter: 1.75 mm
7-10057-07

  • Mechanical atherectomy system catheter, peripheral
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, 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, 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, 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, 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, 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, Exchangeable Series, Handle Only
Cardiovascular Systems, Inc.
DBP-EX-HANDLE
In Commercial Distribution

  • 10850000491035 ()
7-10032-01

  • Mechanical atherectomy system catheter, peripheral
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, 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
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
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
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
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
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
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable
Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
AL-25
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813381 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
AM-25
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding
Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
EVAL-AL-50
In Commercial Distribution

  • 00850054813299 ()
  • 00850054813329 ()
EVAL-AL-50

  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
AS-100
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813084 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
AM-100
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813077 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
AL-100
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813060 ()


  • General-purpose medical fibre padding
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