BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ULITE PHACO HANDPIECE

    DI: 04049539100184 · Model: 303060-0001-000 · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ULITE PHACO HANDPIECE
    Primary DI
    04049539100184
    Version / Model
    303060-0001-000
    Company Name
    Carl Zeiss Meditec AG
    Labeler DUNS
    342228620
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-25
    Public Version
    1
    Public Version Date
    2022-05-03
    Public Version Status
    New
    Public Device Record Key
    75b0649c-c6d6-467e-b0c4-c70895e76997

    Device Description

    This active reusable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.

    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
    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
    Primary 04049539100184