BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ATLAS® Cable System

    DI: 00673978048048 · Model: 826-360 · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ATLAS® Cable System
    Primary DI
    00673978048048
    Version / Model
    826-360
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-18
    Public Version
    5
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    4f127f9a-a237-4bb1-ac58-74d8580a1045
    Distribution End Date
    2018-10-08

    Device Description

    SNGL CABLE W/IC TI NON STERILE

    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
    No
    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
    JDQ CERCLAGE, FIXATION

    GMDN Terms

    Code Name
    61465 Internal spinal fixation system cable, non-sterile

    Identifiers

    Type ID
    Primary 00673978048048

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K920201 000