BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bioclear TwinRing

    DI: D9492080420 · Model: Universal · Bioclear Matrix Systems
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bioclear TwinRing
    Primary DI
    D9492080420
    Version / Model
    Universal
    Company Name
    Bioclear Matrix Systems
    Labeler DUNS
    059020838
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-10
    Public Version
    1
    Public Version Date
    2023-09-18
    Public Version Status
    New
    Public Device Record Key
    fcd5f9b4-5c7c-485d-9c80-7efc2064122b

    Device Description

    Separator ring used in dental restorations.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    33204 Dental matrix band retainer

    Identifiers

    Type ID
    Primary D9492080420