BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAFE DENT

    DI: 00810339031282 · Model: A90143L · BGSS Company Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    SAFE DENT
    Primary DI
    00810339031282
    Version / Model
    A90143L
    Company Name
    BGSS Company Inc.
    Labeler DUNS
    828474952
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2024-05-01
    Public Version
    1
    Public Version Date
    2024-05-09
    Public Version Status
    New
    Public Device Record Key
    1e994ae8-a6f1-42f1-a755-0aeca0d498d4

    Device Description

    A90143L FLOURIDE TRAY DUAL ARCH "large" Bag 100

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KMT Tray, Fluoride, Disposable

    GMDN Terms

    Code Name
    63350 Teeth whitening tray

    Identifiers

    Type ID
    Package 00810339031299
    Primary 00810339031282
    Unit of Use 00810339031275