BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAVANNAH-T

    DI: 00840916116408 · Model: 10-02-6565-52 · SPINAL ELEMENTS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAVANNAH-T
    Primary DI
    00840916116408
    Version / Model
    10-02-6565-52
    Company Name
    SPINAL ELEMENTS
    Labeler DUNS
    004022104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-02
    Public Version
    7
    Public Version Date
    2021-12-10
    Public Version Status
    Update
    Public Device Record Key
    397b53b1-2b14-40d0-b8df-d26604aa618a

    Device Description

    Savannah®-T DualFix Cortical Cancellous Mid-Top Cannulated Screw Assembly, 6.5 x 65mm

    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
    Yes
    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
    NKB Thoracolumbosacral Pedicle Screw System

    GMDN Terms

    Code Name
    61325 Bone-screw internal spinal fixation system, non-sterile

    Identifiers

    Type ID
    Primary 00840916116408