BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STERILIZABLE HANDLE FOR UNICA/U29

    DI: B880Z40030740 · Model: Z400307-4 · RIMSA P. LONGONI SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STERILIZABLE HANDLE FOR UNICA/U29
    Primary DI
    B880Z40030740
    Version / Model
    Z400307-4
    Company Name
    RIMSA P. LONGONI SRL
    Labeler DUNS
    630534840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-16
    Public Version
    1
    Public Version Date
    2020-10-26
    Public Version Status
    New
    Public Device Record Key
    cc0443a1-973c-46b7-97a3-871966fe6e5e

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    FTA Light, Surgical, Accessories

    GMDN Terms

    Code Name
    44975 Medical equipment handle cover, reusable

    Identifiers

    Type ID
    Primary B880Z40030740

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -15 – 60 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 75 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal