BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ExactechGPS Ankle Application

    DI: 10885862634979 · Model: 541-00-01 · Exactech, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    ExactechGPS Ankle Application
    Primary DI
    10885862634979
    Version / Model
    541-00-01
    Catalog Number
    541-00-01
    Company Name
    Exactech, Inc.
    Labeler DUNS
    157565946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-31
    Public Version
    1
    Public Version Date
    2025-08-08
    Public Version Status
    New
    Public Device Record Key
    44d9b910-cc0c-412f-bdef-d8a32d8c66f6

    Device Description

    GPS Ankle Implant Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KDD Kit, surgical instrument, disposable

    GMDN Terms

    Code Name
    44052 Orthopaedic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 10885862634979