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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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SonoVision - 00860001239324

SonoVision Accessory Kit Stabilzer Tube
Tissue Differentiation Intelligence LLC
100021
In Commercial Distribution

  • 00860001239324 ()


  • Interventional radiology percutaneous-access kit, reusable

INTELLAGEN™ Remote Control Kit - 04260166374094

No Description
Stockert GmbH
20403
In Commercial Distribution

  • 04260166374094 ()
M004GEN100204030

  • Cardiac radio-frequency ablation system generator

INTELLAGEN™ Irrigation Pump Kit - 04260166374087

No Description
Stockert GmbH
20402
In Commercial Distribution

  • 04260166374087 ()
M004GEN100204020

  • Bedside infusion pump, single-channel

INTELLAGEN™ RF Generator Kit - 04260166374070

No Description
Stockert GmbH
20401
In Commercial Distribution

  • 04260166374070 ()
M004GEN100204010

  • Cardiac radio-frequency ablation system generator

INTELLAGEN™ Foot Pedal - 04260166373066

No Description
Stockert GmbH
20010
In Commercial Distribution

  • 04260166373066 ()
M004GEN100200100

  • Foot-switch, electrical

2D Linear Probe - 03665134000103

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

2D Abdominal Probe - 03665134000097

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

3D Side Fire Endocavity Probe - 03665134000844

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

3D Side-Fire Endocavity Probe - 03665134000080

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
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system

3D End-Fire Endocavity Probe - 03665134000073

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 and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system
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