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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
Heidelberg Engineering GmbH
Product Family SW V6.8-US
Not in Commercial Distribution

  • 04059237000303 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2610
In Commercial Distribution

  • 04059237000297 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2600
In Commercial Distribution

  • 04059237000280 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Image Capture Module SW V1.2
In Commercial Distribution

  • 04059237000259 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
Flex Module
Heidelberg Engineering GmbH
86549
In Commercial Distribution

  • 04059237000235 ()
86549

  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
HMO
In Commercial Distribution

  • 04059237000211 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
UWF1
In Commercial Distribution

  • 04059237000150 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
WFO2
In Commercial Distribution

  • 04059237000136 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
VAO
In Commercial Distribution

  • 04059237000112 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.6
In Commercial Distribution

  • 04059237000105 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S3610
In Commercial Distribution

  • 04059237000099 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S1610
In Commercial Distribution

  • 04059237000082 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-TSP
In Commercial Distribution

  • 04059237000075 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2001A
In Commercial Distribution

  • 04059237000068 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2000A
In Commercial Distribution

  • 04059237000051 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SP-PWS-1000A
In Commercial Distribution

  • 04059237000044 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S3600
In Commercial Distribution

  • 04059237000037 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2000
In Commercial Distribution

  • 04059237000020 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S1600
In Commercial Distribution

  • 04059237000013 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).
NIDEK CO.,LTD.
Mirante
In Commercial Distribution

  • 04987669101568 ()


  • Scanning-laser retinal imaging system
  • Retinal optical coherence tomography system
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