BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iFuse TORQ Implant System-12.75 mm Tap, Cannulated

    DI: 00855369008477 · Model: 501157-1275 · Si-Bone Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iFuse TORQ Implant System-12.75 mm Tap, Cannulated
    Primary DI
    00855369008477
    Version / Model
    501157-1275
    Company Name
    Si-Bone Inc.
    Labeler DUNS
    830127168
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-08
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    ff0eafb5-23c4-4fe8-8bfd-4c46b206140b

    Device Description

    12.75 mm Tap, Cannulated

    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
    OUR Sacroiliac Joint Fixation

    GMDN Terms

    Code Name
    58849 Sacroiliac joint transarticular fixation/arthrodesis implantation kit

    Identifiers

    Type ID
    Primary 00855369008477

    Customer Contacts

    Phone
    855-884-3873
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K203247 000