BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ATOMO

    DI: D883AA00211 · Model: AA0021 · 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
    D883AA00211
    Version / Model
    AA0021
    Company Name
    ATOMO DENTAL, INC.
    Labeler DUNS
    088480717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-09-09
    Public Version
    1
    Public Version Date
    2022-09-19
    Public Version Status
    New
    Public Device Record Key
    a7d53633-4c3d-423c-91f6-ab95ab0bf566

    Device Description

    ATOMO Isolation gown

    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
    OEA Non-Surgical Isolation Gown

    GMDN Terms

    Code Name
    35492 Isolation gown, single-use

    Identifiers

    Type ID
    Package D883AA00213
    Primary D883AA00211
    Unit of Use D883AA00210