BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Single Use Surgical Professional

    DI: 05055299103050 · Model: S209 · EAKIN SURGICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Single Use Surgical Professional
    Primary DI
    05055299103050
    Version / Model
    S209
    Catalog Number
    S209
    Company Name
    EAKIN SURGICAL LIMITED
    Labeler DUNS
    239505063
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-19
    Public Version
    4
    Public Version Date
    2023-10-25
    Public Version Status
    Update
    Public Device Record Key
    70f1c151-2ba1-425a-a5c3-518949851f58
    Distribution End Date
    2023-10-24

    Device Description

    Leksell Rongeur, 250mm, 8mm Bite

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HTX Rongeur

    GMDN Terms

    Code Name
    64336 Bone-coring punch, single-use

    Identifiers

    Type ID
    Primary 05055299103050
    Package 05055299103067

    Customer Contacts

    Phone
    +440292074740
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Bite Size 8mm
    Length 250 Millimeter