BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Disposable Mixing Well 48/PK-Single Well

    DI: D757X80497P1 · Model: X-80497P · BISCO INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Mixing Well 48/PK-Single Well
    Primary DI
    D757X80497P1
    Version / Model
    X-80497P
    Catalog Number
    X-80497P
    Company Name
    BISCO INC.
    Labeler DUNS
    053529939
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-06
    Public Version
    4
    Public Version Date
    2023-05-04
    Public Version Status
    Update
    Public Device Record Key
    2a8c8a45-3b2a-4e95-81e7-e25441e48743
    Distribution End Date
    2022-11-21

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KXR APPLICATOR, RESIN

    GMDN Terms

    Code Name
    44999 Dental material mixing surface, chairside, single-use

    Identifiers

    Type ID
    Primary D757X80497P1

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify sixe text