IBEX Wireless LED Binocular Indirect Ophthalmoscope

Basic Information

• Brand Name: IBEX Wireless LED Binocular Indirect Ophthalmoscope
• Primary DI: 00869228000434
• Version / Model: BIO
• Company Name: Trevi Technology, Inc.
• Labeler DUNS: 078605507
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 51656a14-e465-47a9-b554-56be3f6658ce

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46792	Indirect binocular ophthalmoscope, line-powered	A mains electricity (AC-powered), ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames and the power is run through a transformer to reduce this to low-voltage.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869228000434	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110205	000