BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Head Frame Cranial Screws, Long

    DI: 10858086006266 · Model: P1008070004 · VARIAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Head Frame Cranial Screws, Long
    Primary DI
    10858086006266
    Version / Model
    P1008070004
    Company Name
    VARIAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    009120817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2021-01-16
    Public Version
    1
    Public Version Date
    2021-01-25
    Public Version Status
    New
    Public Device Record Key
    cfa3e5f7-683e-41d8-a474-349963dfab7f

    Device Description

    Pouch of 2

    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
    MR Unsafe
    Direct Marking Exempt
    Yes
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    IYE Accelerator, linear, medical

    GMDN Terms

    Code Name
    35361 Stereotactic radiosurgical invasive head frame

    Identifiers

    Type ID
    Package 20858086006263
    Primary 10858086006266
    Package 30858086006260
    Unit of Use 00858086006269

    Premarket Submissions

    Submission Number Supplement Number
    K180586 000