BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FRESH Bold Impression Material

    DI: 00815619021267 · Model: Monophase · EXACTA DENTAL PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    FRESH Bold Impression Material
    Primary DI
    00815619021267
    Version / Model
    Monophase
    Catalog Number
    7486
    Company Name
    EXACTA DENTAL PRODUCTS INC
    Labeler DUNS
    016325552
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    4
    Public Version Date
    2022-12-05
    Public Version Status
    Update
    Public Device Record Key
    7a6463d0-8136-4460-887d-06139b251865

    Device Description

    FRESH Bold Impression Material Monophase

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Primary 00815619021267
    Unit of Use 00815619020536