BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iFuse Granite Implant System

    DI: 00810055521135 · Model: 400298-0850 · Si-Bone Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iFuse Granite Implant System
    Primary DI
    00810055521135
    Version / Model
    400298-0850
    Company Name
    Si-Bone Inc.
    Labeler DUNS
    830127168
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-31
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    57f66982-2a75-40c6-88fc-b9050b862c9b

    Device Description

    Bedrock Granite 8.5mm Awl Tip Tap

    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
    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    58849 Sacroiliac joint transarticular fixation/arthrodesis implantation kit

    Identifiers

    Type ID
    Primary 00810055521135

    Customer Contacts

    Phone
    855-884-3873
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K220195 000