Lombart

Basic Information

• Brand Name: Lombart
• Primary DI: 00628308210480
• Version / Model: RT-600-LN-GRY
• Company Name: INNOVA Medical Ophthalmics Inc
• Labeler DUNS: 243325332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-31
• Public Version: 1
• Public Version Date: 2026-04-08
• Public Version Status: New
• Public Device Record Key: 87eb37ad-a93a-40fc-bc99-3a8a60d9edd4

Device Description

Lombart Grey -CYL refractor

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: Yes
• 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
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	886.1770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66911	Phoropter, manual	A manually-operated ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as a manual refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist manually changes the lenses and other settings while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628308210480	GS1