Optina-4C

GUDID 00627987702132

Mydriatic Hyperspectral Retinal Camera (MHRC-C1N)

Optina Diagnostiques, Inc

Ophthalmic fundus camera

• Primary Device ID: 00627987702132
• NIH Device Record Key: cec0dad0-c88a-4937-a1fa-4ca4fc144905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optina-4C
• Version Model Number: MHRC-C1N
• Company DUNS: 203807979
• Company Name: Optina Diagnostiques, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00627987702132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231230

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2024-02-16
• Device Publish Date: 2024-02-08

Devices Manufactured by Optina Diagnostiques, Inc

• 00627987702132 - Optina-4C: 2024-02-16Mydriatic Hyperspectral Retinal Camera (MHRC-C1N)
• 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)