BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SeaSpine

    DI: 00851797006429 · Model: ML-0459 · TEDAN SURGICAL INNOVATIONS, L.L.C.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SeaSpine
    Primary DI
    00851797006429
    Version / Model
    ML-0459
    Company Name
    TEDAN SURGICAL INNOVATIONS, L.L.C.
    Labeler DUNS
    791619393
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-12
    Public Version
    4
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    ba8471b5-db92-4a4b-8390-051ce23919d1

    Device Description

    Disposable Dilator Kit Kit Contains: ML-0444S Insulated Dilator Set, 7, 12, & 15 MM, Sterile ML-0445 Stimulation Clip, 5-22mm, Single Use, 1/Each, Sterile

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IKD Cable, Electrode
    PDQ Neurosurgical Nerve Locator

    GMDN Terms

    Code Name
    35750 Analytical non-scalp cutaneous lead

    Identifiers

    Type ID
    Primary 00851797006429

    Device Sizes

    Type Value Unit Text
    Width 15 Millimeter
    Width 12 Millimeter
    Width 7 Millimeter