BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biofit HD Matrix

    DI: D949318011503 · Model: 4.5 mm Molar · Bioclear Matrix Systems
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Biofit HD Matrix
    Primary DI
    D949318011503
    Version / Model
    4.5 mm Molar
    Company Name
    Bioclear Matrix Systems
    Labeler DUNS
    059020838
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2023-09-11
    Public Version
    1
    Public Version Date
    2023-09-19
    Public Version Status
    New
    Public Device Record Key
    2196cb0c-d7c7-4093-8c14-26c8380b209b

    Device Description

    Clear matrix used in dental restorations.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JEP Retainer, Matrix

    GMDN Terms

    Code Name
    38786 Dental matrix band, single-use

    Identifiers

    Type ID
    Unit of Use D9493180110
    Primary D949318011503