Marco

GUDID 00860014277559

CAMERA, OPHTHALMIC, GENERAL-USE

Lombart Brothers, Inc.

Ophthalmic fundus camera

• Primary Device ID: 00860014277559
• NIH Device Record Key: 2aa2bc16-2a47-4a29-a38e-fc4178ea4276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Marco
• Version Model Number: Marco iON
• Company DUNS: 097420376
• Company Name: Lombart Brothers, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014277559 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-10
• Device Publish Date: 2026-03-02

Devices Manufactured by Lombart Brothers, Inc.

• 00860014277559 - Marco: 2026-03-10CAMERA, OPHTHALMIC, GENERAL-USE
• 00860014277559 - Marco: 2026-03-10 CAMERA, OPHTHALMIC, GENERAL-USE
• 00860014277511 - Advancing Eyecare: 2025-08-05 AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.
• 00860014277504 - Advancing Eyecare: 2025-07-29 For checking the refractive state of human eye.