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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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PROMAP LITE – 3D PROSTATE SUITE - 03665134000714

ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure.
KOELIS
KSOF-2602
In Commercial Distribution

  • 03665134000714 ()


  • Image segmentation application software

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 - 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

Cavex ImpreSafe container - E241HT0200

Dental impression disinfectant
Cavex Holland B.V.
HT020
In Commercial Distribution

  • E241HT0200 ()

  • 1 pcs
HT020

  • Denture cleanser

Cavex ImpreSafe starterkit - E241HA0530

Dental impression disinfectant
Cavex Holland B.V.
HA053
In Commercial Distribution

  • E241HA0530 ()

  • 1 pcs
HA053

  • Denture cleanser

Cavex GreenClean sample - E241HA0030

Dental cleaning agent
Cavex Holland B.V.
HA003
In Commercial Distribution

  • E241HA0030 ()

  • 1 pcs
HA003

  • Denture cleanser

Cavex Temporary Cement - E241CE0900

Dental Cement
Cavex Holland B.V.
CE090
In Commercial Distribution

  • E241CE0900 ()

  • 1 pcs
CE090

  • Temporary dental filling material

Cavex Bite&White ABC Masterkit - E241BW0900

Dental Whitening Agent
Cavex Holland B.V.
BW090
In Commercial Distribution

  • E241BW0900 ()

  • 1 pcs
BW090

  • Dental bleaching agent
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