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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ref-Line

    DI: EPOLREFV1B10 · Model: REF.V1B1 · POLIDENT d.o.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ref-Line
    Primary DI
    EPOLREFV1B10
    Version / Model
    REF.V1B1
    Catalog Number
    REF.V1B1
    Company Name
    POLIDENT d.o.o.
    Labeler DUNS
    644778409
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-09
    Public Version
    1
    Public Version Date
    2024-12-17
    Public Version Status
    New
    Public Device Record Key
    de227a81-f565-4f78-b01a-2f5496048cf3

    Device Description

    REFV1B1

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELM Denture, Plastic, Teeth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary EPOLREFV1B10

    Customer Contacts

    Phone
    +38653304840
    Email
    [email protected]