BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ATOMO

    DI: D883AA08041 · Model: AA0804 · ATOMO DENTAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    ATOMO
    Primary DI
    D883AA08041
    Version / Model
    AA0804
    Company Name
    ATOMO DENTAL, INC.
    Labeler DUNS
    088480717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-09-07
    Public Version
    1
    Public Version Date
    2022-09-15
    Public Version Status
    New
    Public Device Record Key
    00dd69c0-8334-47ea-a9b6-7b223f9366dd

    Device Description

    ATOMO Disposable Impression Trays, Medium Lower

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EHY Tray, Impression, Preformed

    GMDN Terms

    Code Name
    16350 Dental impression tray, single-use

    Identifiers

    Type ID
    Package D883AA08043
    Primary D883AA08041
    Unit of Use D883AA08040