BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WayPoint™ Standoff Wrench

    DI: 00873263007280 · Model: 66-WP-SW-00728 · FHC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WayPoint™ Standoff Wrench
    Primary DI
    00873263007280
    Version / Model
    66-WP-SW-00728
    Catalog Number
    66-WP-SW
    Company Name
    FHC, INC.
    Labeler DUNS
    108179458
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-19
    Public Version
    2
    Public Version Date
    2021-06-15
    Public Version Status
    Update
    Public Device Record Key
    932a43cc-a3cc-4923-b80b-bdfd2a98ae19

    Device Description

    microTargeting WayPoint Standoff Tool/Wrench, 1x, nonsterile, for use with STar Drive

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HAW Neurological stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Direct Marking 00873263007297
    Primary 00873263007280

    Customer Contacts

    Phone
    +1(800)326-2905
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K092562 000