BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mydriatic Hyperspectral Retinal Camera

    DI: 00627987702125 · Model: MHRC-C1 · Optina Diagnostiques, Inc
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mydriatic Hyperspectral Retinal Camera
    Primary DI
    00627987702125
    Version / Model
    MHRC-C1
    Company Name
    Optina Diagnostiques, Inc
    Labeler DUNS
    203807979
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-07
    Public Version
    2
    Public Version Date
    2023-05-16
    Public Version Status
    Update
    Public Device Record Key
    02ed2d55-fa38-428a-86d4-d980ffd56b54

    Device Description

    Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    HKI Camera, Ophthalmic, Ac-Powered
    NFJ System, Image Management, Ophthalmic

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 00627987702125

    Premarket Submissions

    Submission Number Supplement Number
    K200254 000