BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OTHER EXTERNAL FIXATION

    DI: 00885556012062 · Model: 71061001 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OTHER EXTERNAL FIXATION
    Primary DI
    00885556012062
    Version / Model
    71061001
    Catalog Number
    71061001
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-29
    Public Version
    4
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    3d4717b5-970c-4858-b2ca-0e3c946fa567

    Device Description

    3.2MM X 86MM TROCAR PIN

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JDW PIN, FIXATION, THREADED

    GMDN Terms

    Code Name
    62746 Orthopaedic trocar blade, single-use

    Identifiers

    Type ID
    Package 20885556012066
    Primary 00885556012062

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K120871 000