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 ID: 00869228000434
• NIH Device Record Key: 51656a14-e465-47a9-b554-56be3f6658ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBEX Wireless LED Binocular Indirect Ophthalmoscope
• Version Model Number: BIO
• Company DUNS: 078605507
• Company Name: Trevi Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 614-754-7175
• Email: info@ibexeye.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869228000434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110205

FDA Product Code

• HLI: Ophthalmoscope, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-01

Devices Manufactured by Trevi Technology, Inc.

• 00869228000472 - IBEX Keratometer: 2019-08-09 IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the exten
• 00869228000410 - IBEX 5-step LED slit lamp: 2018-07-06 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 lamp: 2018-07-06 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 Tonometer: 2018-07-06 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 chart: 2018-03-29 The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive sy