BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Stable-L™

    DI: B6788250790 · Model: 825079 · NEXUS SPINE, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Stable-L™
    Primary DI
    B6788250790
    Version / Model
    825079
    Company Name
    NEXUS SPINE, L.L.C.
    Labeler DUNS
    028137605
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-31
    Public Version
    4
    Public Version Date
    2023-08-16
    Public Version Status
    Update
    Public Device Record Key
    031e5d99-991d-4a8b-858e-d35a661f7cb6
    Distribution End Date
    2023-08-15

    Device Description

    Stable-L Cranial Guide, 18mm

    Device Characteristics

    Single Use
    Yes
    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    47870 Orthopaedic fixation implant alignment tool

    Identifiers

    Type ID
    Primary B6788250790