BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SML

    DI: D85463603L1 · Model: 63603L · 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
    D85463603L1
    Version / Model
    63603L
    Company Name
    SELANE PRODUCTS, INC.
    Labeler DUNS
    066642729
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-04
    Public Version
    4
    Public Version Date
    2021-10-11
    Public Version Status
    Update
    Public Device Record Key
    778dbe40-0162-4528-97fc-d12a77fe8d27

    Device Description

    FULL BREATH LOWER-THERMAL ACY W/ PTR

    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
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LRK Device, Anti-Snoring

    GMDN Terms

    Code Name
    62239 Tongue-training sleep-disordered breathing orthosis

    Identifiers

    Type ID
    Primary D85463603L1