Optina Fotys

GUDID 00627987702149

Optina Diagnostiques, Inc

Medical image management system

• Primary Device ID: 00627987702149
• NIH Device Record Key: ac91b1d1-798b-4d4d-a669-07a6d1382a67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optina Fotys
• Version Model Number: 1.0.1
• Company DUNS: 203807979
• Company Name: Optina Diagnostiques, 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: true
• 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	00627987702149 [Primary]

FDA Product Code

• NFG: Device, Communications, Images, Ophthalmic

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: 2025-09-08
• Device Publish Date: 2025-08-29

Devices Manufactured by Optina Diagnostiques, Inc

• 00627987702149 - Optina Fotys: 2025-09-08
• 00627987702149 - Optina Fotys: 2025-09-08
• 00627987702132 - Optina-4C: 2024-02-16 Mydriatic Hyperspectral Retinal Camera (MHRC-C1N)
• 00627987702125 - Mydriatic Hyperspectral Retinal Camera: 2021-06-15 Mydriatic Hyperspectral Retinal Camera (MHRC-C1)