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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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The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer. In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features: • Image analysis functions such as 3D/map color display or retinal thickness analysis • Networking for data review or analysis on PCs in separate locations
NIDEK CO.,LTD.
RS-3000 Advance
In Commercial Distribution

  • 04987669100516 ()


  • Direct ophthalmoscope, line-powered
No Description
BONART CO., LTD.
LCC-120A
In Commercial Distribution

  • 04719873120666 ()


  • Dental power tool system handpiece, line-powered
No Description
BONART CO., LTD.
LSC-101A
In Commercial Distribution

  • 04719873120215 ()


  • Dental power tool system handpiece, line-powered
No Description
IMEDICOM CO., LTD.
BRBH-101S
In Commercial Distribution

  • 00887919873204 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
No Description
IMEDICOM CO., LTD.
BRPZ-1000
In Commercial Distribution

  • 00887919873181 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
No Description
IMEDICOM CO., LTD.
BRBC.300
In Commercial Distribution

  • 00887919874447 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
No Description
IMEDICOM CO., LTD.
BRBSC.100
In Commercial Distribution

  • 00887919874416 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
No Description
IMEDICOM CO., LTD.
BRBHC.100
In Commercial Distribution

  • 00887919874386 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
No Description
IMEDICOM CO., LTD.
BRBHL.100
In Commercial Distribution

  • 00887919874355 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
No Description
IMEDICOM CO., LTD.
BRHC.100
In Commercial Distribution

  • 00887919874324 ()


  • Surgical power tool system handpiece, rotary, rechargeable battery-powered
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