BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Safety filter for Zeiss/Moeller-Wedel Microscopes, Passive

    DI: 08717872019703 · Model: 8005.F3 · D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Safety filter for Zeiss/Moeller-Wedel Microscopes, Passive
    Primary DI
    08717872019703
    Version / Model
    8005.F3
    Catalog Number
    8005.F3
    Company Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    Labeler DUNS
    407522184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    1df937f9-9076-43c9-9ae7-ebf18294bbef

    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
    HQC Unit, Phacofragmentation

    GMDN Terms

    Code Name
    36308 Operator eye protection laser filter

    Identifiers

    Type ID
    Primary 08717872019703

    Premarket Submissions

    Submission Number Supplement Number
    K142877 000