BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RIVA LUTING

    DI: DO3686501081 · Model: RIVA LUTING LY PWD REF 35 · SDI LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RIVA LUTING
    Primary DI
    DO3686501081
    Version / Model
    RIVA LUTING LY PWD REF 35
    Catalog Number
    8650108
    Company Name
    SDI LIMITED
    Labeler DUNS
    753221852
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-07
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    52bbe99e-6aa4-4c5e-bf2a-5e4df94a1a37

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EMA CEMENT, DENTAL

    GMDN Terms

    Code Name
    16704 Glass ionomer dental cement

    Identifiers

    Type ID
    Primary DO3686501081

    Customer Contacts

    Phone
    +18002285166
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K040393 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    5 – 25 Degrees Celsius