BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sophysa

    DI: 03760124132076 · Model: PSO-4000 · SOPHYSA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sophysa
    Primary DI
    03760124132076
    Version / Model
    PSO-4000
    Company Name
    SOPHYSA
    Labeler DUNS
    262951353
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-25
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    77e48873-e253-4c38-b9e8-8226cb246fdd

    Device Description

    PRESSIO 2 ICP MONITOR

    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
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWM DEVICE, MONITORING, INTRACRANIAL PRESSURE

    GMDN Terms

    Code Name
    16763 Intracranial pressure monitor

    Identifiers

    Type ID
    Primary 03760124132076