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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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Visionix - 03664188000381

No Description
LUNEAU TECHNOLOGY OPERATIONS
Nexy
In Commercial Distribution

  • 03664188000381 ()


  • Ophthalmic fundus camera

RetiCapture - 08800023201017

No Description
ILOODA.CO.,LTD
RetiCapture
In Commercial Distribution

  • 08800023201017 ()


  • Ophthalmic fundus camera

Fundus Camera HFC-1 - 08800019600541

HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Huvitz Co., Ltd.
HFC-1
In Commercial Distribution

  • 08800019600541 ()
HFC-1

  • Ophthalmic fundus camera

HiPAL Pro - G527GTDHIPALPRO01V1010

HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.
GT DIAGNOSTICS (UK) LIMITED
1.0.1
In Commercial Distribution

  • G527GTDHIPALPRO01V1010 ()
GTD-HiPALPro-01

  • Cognitive assessment software

Bowman Perfusion Monitor, 240V - B238H000107110

Perfusion Monitor, 240V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000107110 ()
H0001-0711

  • Patient monitoring system module, intracranial pressure

Bowman Perfusion Monitor, 120V - B238H000007100

Perfusion Monitor, 120V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000007100 ()
H0000-0710

  • Patient monitoring system module, intracranial pressure

Neolight - 20852788008051

ICON GO & FA
NEOLIGHT LLC
PCI 40-2100FA
In Commercial Distribution

  • 20852788008051 ()


  • Ophthalmic fundus camera

Neolight - 20852788008044

ICON GO
NEOLIGHT LLC
PCI 40-2100
In Commercial Distribution

  • 20852788008044 ()


  • Ophthalmic fundus camera

Neolight - 20852788008037

ICON Cart
NEOLIGHT LLC
PCI 40-1100
In Commercial Distribution

  • 20852788008037 ()


  • Ophthalmic fundus camera

Neolight - 20852788008020

ICON Cart & FA
NEOLIGHT LLC
PCI 40-1100FA
In Commercial Distribution

  • 20852788008020 ()


  • Ophthalmic fundus camera
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