BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VivaPen Sleeves

    DI: DVIV6274921 · Model: 627492 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    300

    Basic Information

    Brand Name
    VivaPen Sleeves
    Primary DI
    DVIV6274921
    Version / Model
    627492
    Catalog Number
    627492
    Company Name
    IVOCLAR VIVADENT AKTIENGESELLSCHAFT
    Labeler DUNS
    448015938
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    300
    Record Status
    Published
    Publish Date
    2021-10-05
    Public Version
    1
    Public Version Date
    2021-10-13
    Public Version Status
    New
    Public Device Record Key
    e5222b6b-7fe1-48bf-a094-e7980e95f224

    Device Description

    VivaPen Sleeves Refill 300 New

    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
    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
    PEM Dental barriers and sleeves

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Unit of Use DVIV6274920
    Primary DVIV6274921