BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula

    DI: 00810055522019 · Model: 501518 · Si-Bone Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula
    Primary DI
    00810055522019
    Version / Model
    501518
    Company Name
    Si-Bone Inc.
    Labeler DUNS
    830127168
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    b811fd1a-55fb-458d-95f9-4c7f9a288943

    Device Description

    T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula

    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    58849 Sacroiliac joint transarticular fixation/arthrodesis implantation kit

    Identifiers

    Type ID
    Primary 00810055522019

    Customer Contacts

    Phone
    855-884-3873
    Email
    [email protected]