BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPMI® LUMERA® 300

    DI: 06909262061375 · Model: 6137 · Carl Zeiss Suzhou Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPMI® LUMERA® 300
    Primary DI
    06909262061375
    Version / Model
    6137
    Company Name
    Carl Zeiss Suzhou Co., Ltd.
    Labeler DUNS
    528182577
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-11
    Public Version
    2
    Public Version Date
    2023-08-17
    Public Version Status
    Update
    Public Device Record Key
    b5ce0121-05e5-4cc6-883a-9eb8adf63e8e

    Device Description

    No description

    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
    FSO Microscope, Surgical, General & Plastic Surgery
    HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

    GMDN Terms

    Code Name
    64676 Ophthalmic surgical microscope

    Identifiers

    Type ID
    Primary 06909262061375