BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HeatSync

    DI: D9494170131 · Model: Mini · Bioclear Matrix Systems
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HeatSync
    Primary DI
    D9494170131
    Version / Model
    Mini
    Company Name
    Bioclear Matrix Systems
    Labeler DUNS
    059020838
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-10
    Public Version
    1
    Public Version Date
    2023-08-18
    Public Version Status
    New
    Public Device Record Key
    e0be6c98-9144-45bc-95f0-791c32e228b5

    Device Description

    Warmer for composite used in dental restorations.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    High-level Disinfectant

    GMDN Terms

    Code Name
    65223 Dental material heater

    Identifiers

    Type ID
    Primary D9494170131