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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHACO SET PLUS 21G,BICONICAL,30°

    DI: 04049539102508 · Model: 303060-1024-000 · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHACO SET PLUS 21G,BICONICAL,30°
    Primary DI
    04049539102508
    Version / Model
    303060-1024-000
    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
    2
    Public Version Date
    2024-01-31
    Public Version Status
    Update
    Public Device Record Key
    e077889d-00db-4af7-89c8-110fabc21b10

    Device Description

    This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery. (consists of TEST CHAMBER, PHACO TIP and SILICONE SLEEVE).

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HQC Unit, Phacofragmentation

    GMDN Terms

    Code Name
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 04049539103888
    Primary 04049539102508