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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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iFusion - 00858848006230

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

iFusion - 00858848006209

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

iFusion - 00858848006193

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

iFusion - 00858848006179

iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006179 ()
700-49000-004

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

Tracey-VFA Visual Function Analyzer - 00860479001706

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

iFusion - 00858848006308

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

iFusion - 00858848006292

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

iFusion - 00858848006186

iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006186 ()
700-49001-004

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

Pathway - 00852423006028

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 - 00852423006011

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
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