BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nylon Herbst Sleep

    DI: D775INIST0 · Model: INIST · Great Lakes Dental Technologies, Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Nylon Herbst Sleep
    Primary DI
    D775INIST0
    Version / Model
    INIST
    Company Name
    Great Lakes Dental Technologies, Ltd.
    Labeler DUNS
    041854332
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-13
    Public Version
    1
    Public Version Date
    2026-04-21
    Public Version Status
    New
    Public Device Record Key
    a6d5ce06-a4ed-42c5-b9fc-519a913f92c3

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    PM Exempt
    No
    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
    LRK Device, Anti-Snoring

    GMDN Terms

    Code Name
    47528 Palate-lifting sleep-disordered breathing orthosis

    Identifiers

    Type ID
    Primary D775INIST0

    Premarket Submissions

    Submission Number Supplement Number
    K955822 000