Mydriatic Hyperspectral Retinal Camera

GUDID 00627987702125

Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

Optina Diagnostiques, Inc

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera

• Primary Device ID: 00627987702125
• NIH Device Record Key: 02ed2d55-fa38-428a-86d4-d980ffd56b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mydriatic Hyperspectral Retinal Camera
• Version Model Number: MHRC-C1
• Company DUNS: 203807979
• Company Name: Optina Diagnostiques, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627987702125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200254

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: 2021-06-15
• Device Publish Date: 2021-06-07

Devices Manufactured by Optina Diagnostiques, Inc

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