IBEX Wireless LED Binocular Indirect Ophthalmoscope

GUDID 00869228000434

IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities.

Trevi Technology, Inc.

Indirect binocular ophthalmoscope, line-powered
Primary Device ID00869228000434
NIH Device Record Key51656a14-e465-47a9-b554-56be3f6658ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBEX Wireless LED Binocular Indirect Ophthalmoscope
Version Model NumberBIO
Company DUNS078605507
Company NameTrevi Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone614-754-7175
Emailinfo@ibexeye.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100869228000434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLIOphthalmoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-01

Devices Manufactured by Trevi Technology, Inc.

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00869228000410 - IBEX 5-step LED slit lamp2018-07-06 IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures i
00869228000427 - IBEX 2-step LED slit lamp2018-07-06 IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures i
00869228000434 - IBEX Wireless LED Binocular Indirect Ophthalmoscope 2018-07-06IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities.
00869228000434 - IBEX Wireless LED Binocular Indirect Ophthalmoscope 2018-07-06 IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high re
00869228000441 - Applanation Tonometer2018-07-06 IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cor
00869228000458 - IBEX LCD digital acuity chart2018-03-29 The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive sy

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