BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tether Extension Cable Male-to-Male 3m

    DI: 00850011306307 · Model: 3 meter · NEURALYNX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tether Extension Cable Male-to-Male 3m
    Primary DI
    00850011306307
    Version / Model
    3 meter
    Catalog Number
    31-0613-0031
    Company Name
    NEURALYNX, INC.
    Labeler DUNS
    933200842
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-19
    Public Version
    1
    Public Version Date
    2026-02-27
    Public Version Status
    New
    Public Device Record Key
    84284415-35f5-4a57-a36d-54721a136e50

    Device Description

    The Tether Extension Cable Male-to-Male 3m is a component of the ATLAS Neurophysiology System.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IKD Cable, Electrode

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00850011306307

    Customer Contacts

    Phone
    4065854542
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K110967 000