BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FITBONE®

    DI: 04260170143723 · Model: CS 115V -A · WITTENSTEIN intens GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FITBONE®
    Primary DI
    04260170143723
    Version / Model
    CS 115V -A
    Catalog Number
    60001644
    Company Name
    WITTENSTEIN intens GmbH
    Labeler DUNS
    315887799
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-22
    Public Version
    7
    Public Version Date
    2023-01-06
    Public Version Status
    Update
    Public Device Record Key
    187fb098-5aa5-4d1c-89b3-7299b86e6009
    Distribution End Date
    2022-12-31

    Device Description

    Control Set for activation of intramedullary lengthening nail

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HSB Rod, Fixation, Intramedullary And Accessories

    GMDN Terms

    Code Name
    43538 Distraction plate/rod adjustment remote control

    Identifiers

    Type ID
    Primary 04260170143723

    Customer Contacts

    Phone
    +4979314930
    Email
    [email protected]