BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Integrity-SI Fusion System

    DI: B57112524401D0 · Model: 1252-4401 · Lincotek Medical LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Integrity-SI Fusion System
    Primary DI
    B57112524401D0
    Version / Model
    1252-4401
    Catalog Number
    1252-4401
    Company Name
    Lincotek Medical LLC
    Labeler DUNS
    117021487
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-16
    Public Version
    4
    Public Version Date
    2023-11-16
    Public Version Status
    Update
    Public Device Record Key
    f34d4f74-0c1b-4935-8c59-dd3548038c80
    Distribution End Date
    2022-01-24

    Device Description

    24mm Nav Sleeve

    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
    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
    OUR Sacroiliac Joint Fixation

    GMDN Terms

    Code Name
    58849 Sacroiliac joint transarticular fixation/arthrodesis implantation kit

    Identifiers

    Type ID
    Primary B57112524401D0