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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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No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030010 ()
  • EFIAE0030011 ()
  • 04260759931512 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram
E 00 3001

  • Multi-purpose stereotactic surgery system
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030001 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram


  • Multi-purpose stereotactic surgery system
The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System. The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAA0127041 ()


  • Multi-purpose stereotactic surgery system
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SM-200-003
In Commercial Distribution

  • B815SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use
No Description
WITHINGS
HWA09
In Commercial Distribution

  • 13700546706407 ()
  • 03700546706400 ()
  • 23700546706404 ()


  • Wearable multiple physiological parameter recorder, reusable
No Description
SWAN MEDICAL SL.
FA-RL01
In Commercial Distribution

  • 08437016917015 ()


  • Basic power supply, reusable
Compact PERINE Probe. Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00-2
In Commercial Distribution

  • 03665134000851 ()
  • 03665134000844 ()
K3DEL00-2

  • General-purpose ultrasound imaging system
A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
KOELIS
KURO-3000-3
In Commercial Distribution

  • 03665134000691 ()
  • 03665134000684 ()
  • 03665134000707 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system
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