BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Head Frame Cranial Screws - Long and Short

    DI: 00858086006283 · Model: P1006801006 · VARIAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Head Frame Cranial Screws - Long and Short
    Primary DI
    00858086006283
    Version / Model
    P1006801006
    Company Name
    VARIAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    009120817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    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
    483dc247-ca44-403f-8774-b4349cd3c6aa

    Device Description

    Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2

    Device Characteristics

    Single Use
    No
    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 10858086006280
    Primary 00858086006283

    Premarket Submissions

    Submission Number Supplement Number
    K180586 000