BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SML

    DI: D854620651 · Model: 62065 · SELANE PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SML
    Primary DI
    D854620651
    Version / Model
    62065
    Company Name
    SELANE PRODUCTS, INC.
    Labeler DUNS
    066642729
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-21
    Public Version
    1
    Public Version Date
    2020-03-02
    Public Version Status
    New
    Public Device Record Key
    92572acc-87f4-4b8b-9461-60e53a70e24b

    Device Description

    The POD

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQC Mouthguard, Prescription

    GMDN Terms

    Code Name
    38620 Custom-made mouthguard

    Identifiers

    Type ID
    Primary D854620651

    Premarket Submissions

    Submission Number Supplement Number
    K182820 000