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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, 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, 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, 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, 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, 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
Scan abutment Engaging Ø 4,0 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566624872 ()
IPD/WB-SR-02

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan abutment Non-Engaging Ø 4,0 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566624865 ()
IPD/WB-SR-01

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan abutment Engaging Ø 4,0 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566624858 ()
IPD/WB-SR-00

  • Dental implant abutment analog, intraoral-scanning, single-use
The G5 Flimm-Fighter Percussor is the optimum percussor for effective postural drainage at home. The Flimm-Fighter incorporates Directional-Stroking action that helps loosen congestive materials and then moves them into the upper airways, thus promoting airway clearance. The red arrow on the head of the Flimm-Fighter shows the user the direction that the loosened materials are moving inside the body. The ultra-light applicator head, weighing less than one pound, allows a patient to effortlessly receive or self-administer therapy, as it is designed for use with our self application pillow*. The continuously-variable speed range of 20 - 30 cycles per second ensures that patients receive safe, thorough treatment. Comes with applicators 250, 251, 253 & 234. A pediatric version is also available. Unit Advantages: Ideal for COPD, Cystic Fibrosis, Bronchiectasis, Chronic Bronchitis, Atelectasis, Asthma, and Bronchopulmonary Dysplasia patients needing postural drainage Extremely lightweight, the Flimm-Fighter handle weighs less than 1 pound Speed: 20 - 30 cycles per second Can be used with our self application kit* and the Vari-Tilt body positioner *Self Application Kit available separately.
GENERAL PHYSIOTHERAPY INC
FF24B
In Commercial Distribution

  • 00746980000356 ()

  • Weight: 12 Pound
FF24B

  • Hand-held electric massager
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
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