BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIOM 6

    DI: 04049584037152 · Model: 10034820 · OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BIOM 6
    Primary DI
    04049584037152
    Version / Model
    10034820
    Company Name
    OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317138956
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-14
    Public Version
    1
    Public Version Date
    2026-01-22
    Public Version Status
    New
    Public Device Record Key
    2dba6d35-e40c-4414-9cd6-f3a8915f1b17

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

    GMDN Terms

    Code Name
    64676 Ophthalmic surgical microscope

    Identifiers

    Type ID
    Primary 04049584037152