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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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Galilei G6 Lens Professional
SIS AG, Surgical Instrument Systems
G6
In Commercial Distribution

  • 07640167751242 ()
410.030.007

  • Optical low coherence reflectometry (OLCR) biometer
  • Eye anterior segment analyser
  • Corneal topography system application software
The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
TRACEY TECHNOLOGIES, CORPORATION
iTrace
In Commercial Distribution

  • 00860479001706 ()
Z2000

  • Corneal topography system
  • Automated ophthalmic refractometer
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
iVue NR for iFusion USCFG System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006308 ()
700-48586-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006292 ()
700-48585-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006247 ()
700-48371-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006230 ()
700-48363-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006209 ()
700-49003-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006193 ()
700-49002-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
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