BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    2.2 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab

    DI: 08717872033020 · Model: 3430.22AF1 · D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    2.2 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab
    Primary DI
    08717872033020
    Version / Model
    3430.22AF1
    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
    6
    Record Status
    Published
    Publish Date
    2021-05-12
    Public Version
    1
    Public Version Date
    2021-05-20
    Public Version Status
    New
    Public Device Record Key
    acceb2aa-b571-4c3c-b8b9-a051fb689d91

    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
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HQC Unit, Phacofragmentation

    GMDN Terms

    Code Name
    34900 Phacoemulsification system handpiece

    Identifiers

    Type ID
    Unit of Use 18717872033027
    Primary 08717872033020

    Premarket Submissions

    Submission Number Supplement Number
    K190875 000