BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    One-Step

    DI: 10810111540930 · Model: U-1101P · BISCO INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    One-Step
    Primary DI
    10810111540930
    Version / Model
    U-1101P
    Catalog Number
    U-1101P
    Company Name
    BISCO INC.
    Labeler DUNS
    053529939
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-02
    Public Version
    2
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    2e2527bf-a120-4459-b892-96c956412c27

    Device Description

    One-Step 4ml Bottle Pkg

    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
    34782 Dentine bonding agent/set

    Identifiers

    Type ID
    Primary 10810111540930
    Previous D757U1101P1

    Customer Contacts

    Phone
    +1(847)534-6000
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 25 Degrees Celsius