BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OMA (810 nm)

    DI: 00813125010591 · Model: 11671 · IRIDEX CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OMA (810 nm)
    Primary DI
    00813125010591
    Version / Model
    11671
    Company Name
    IRIDEX CORPORATION
    Labeler DUNS
    612920785
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-06
    Public Version
    2
    Public Version Date
    2025-05-22
    Public Version Status
    Update
    Public Device Record Key
    eb43165e-790a-4614-9dad-fef6326facd8

    Device Description

    OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope

    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
    HQF Laser, Ophthalmic
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60341 General/multiple surgical diode laser system

    Identifiers

    Type ID
    Primary 00813125010591

    Customer Contacts

    Phone
    1-800-388-4747
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K020374 000