BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T2 STRATOSPHERE™ Expandable Corpectomy System

    DI: 00643169663213 · Model: 436025A · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T2 STRATOSPHERE™ Expandable Corpectomy System
    Primary DI
    00643169663213
    Version / Model
    436025A
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-28
    Public Version
    2
    Public Version Date
    2023-09-13
    Public Version Status
    Update
    Public Device Record Key
    3faeb6e3-3fb1-4ff0-a460-831942887ab2

    Device Description

    CENTERPIECE 436025A 25MM A-SIZE

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    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
    MQP Spinal vertebral body replacement device

    GMDN Terms

    Code Name
    34170 Vertebral body prosthesis

    Identifiers

    Type ID
    Primary 00643169663213

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K173125 000