BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OFIX

    DI: 17540279100020 · Model: 10-002 · Icentia Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    OFIX
    Primary DI
    17540279100020
    Version / Model
    10-002
    Company Name
    Icentia Inc.
    Labeler DUNS
    241983607
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2024-03-26
    Public Version
    4
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    f3757d5f-10fd-4839-b3ce-0c6d349ff806

    Device Description

    OFIX adhesive disks

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGX Tape And Bandage, Adhesive

    GMDN Terms

    Code Name
    61069 Cable/lead/sensor non-conductive skin-adherent patch, single-use

    Identifiers

    Type ID
    Primary 17540279100020
    Unit of Use 17540279001020