BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FIXIT

    DI: 03760154003520 · Model: Complete FIXIT basket 1st + 2nd rows · S.B.M
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FIXIT
    Primary DI
    03760154003520
    Version / Model
    Complete FIXIT basket 1st + 2nd rows
    Catalog Number
    EPA9000002
    Company Name
    S.B.M
    Labeler DUNS
    772462123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-12
    Public Version
    1
    Public Version Date
    2024-06-20
    Public Version Status
    New
    Public Device Record Key
    0b771ef1-85ac-49d7-bfd4-a08a87dbe2e8

    Device Description

    Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st + 2nd rows).

    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
    Yes
    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44091 Arthroscopic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 03760154003520