BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reusable Instruments used with SOVEREIGN® Spinal System

    DI: 00613994320568 · Model: 7965210 · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Reusable Instruments used with SOVEREIGN® Spinal System
    Primary DI
    00613994320568
    Version / Model
    7965210
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-20
    Public Version
    3
    Public Version Date
    2019-02-07
    Public Version Status
    Update
    Public Device Record Key
    912eae61-3d5a-4612-ae18-1e2fb46dad70

    Device Description

    TRIAL 7965210 M 37X27 10MM 12 DEG

    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
    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
    MAX Intervertebral fusion device with bone graft, lumbar

    GMDN Terms

    Code Name
    44788 Spinal implant trial

    Identifiers

    Type ID
    Primary 00613994320568

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Width 10.0 Millimeter
    Height 27.0 Millimeter
    Length 37.0 Millimeter