BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    WayPoint™ Fiducial Placement Template

    DI: 00873263008393 · Model: 66-DA-FT-03-00839 · FHC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WayPoint™ Fiducial Placement Template
    Primary DI
    00873263008393
    Version / Model
    66-DA-FT-03-00839
    Catalog Number
    66-DA-FT-03
    Company Name
    FHC, INC.
    Labeler DUNS
    108179458
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-22
    Public Version
    3
    Public Version Date
    2022-01-21
    Public Version Status
    Update
    Public Device Record Key
    b1c9ed12-e387-431a-b8d9-4047854828cd
    Distribution End Date
    2022-01-20

    Device Description

    WayPoint Fiducial Placement Template, 10x, nonsterile

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAW Neurological stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 00873263008393
    Package 10873263008390

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K092192 000