IBEX Keratometer

Basic Information

• Brand Name: IBEX Keratometer
• Primary DI: 00869228000472
• Version / Model: MK
• 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: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 044a31e8-d075-44f1-a31e-a1a22ac72451

Device Description

IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the extent and axis of astigmatism.

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: Yes
• 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
HLQ	Keratoscope, Ac-Powered	Ophthalmic	886.1350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16347	Keratoscope, powered	An electrically-powered ophthalmic device intended for qualitative assessment of the curvature of the anterior surface of the cornea, typically to detect astigmatism during ophthalmic surgery; it is not a keratometer. It may be designed as a hand-held instrument or to be mounted on a device (e.g., on an ophthalmic surgical microscope) and emits concentric rings of light onto the corneal surface (similar to a Placido disk) whereby the distorted reflection of the light rings on the cornea of the patient is indicative of astigmatism. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869228000472	GS1

Customer Contacts

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