BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EM Probe Bracket Kit, C1-5, Single

    DI: 00850044606023 · Model: SPEC-0310 · Mediview Xr, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EM Probe Bracket Kit, C1-5, Single
    Primary DI
    00850044606023
    Version / Model
    SPEC-0310
    Company Name
    Mediview Xr, Inc.
    Labeler DUNS
    117407269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-23
    Public Version
    1
    Public Version Date
    2023-10-31
    Public Version Status
    New
    Public Device Record Key
    7c169302-bc26-43e4-a819-f479dc1b2096

    Device Description

    MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers.

    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    64600 Ultrasound imaging system tracking positioner, single-use

    Identifiers

    Type ID
    Primary 00850044606023
    Package 10850044606020

    Premarket Submissions

    Submission Number Supplement Number
    K223125 000