BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Promaxo MRI System

    DI: 00860006901110 · Model: PR071-001-M · Promaxo, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Promaxo MRI System
    Primary DI
    00860006901110
    Version / Model
    PR071-001-M
    Catalog Number
    PR071-001-M
    Company Name
    Promaxo, Inc.
    Labeler DUNS
    103665187
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-19
    Public Version
    1
    Public Version Date
    2022-04-27
    Public Version Status
    New
    Public Device Record Key
    9ab0949d-069b-4a43-a9f0-6372fa4fe7e8

    Device Description

    Magnetic Resonance Imaging System, Magnet Cart

    Device Characteristics

    Single Use
    No
    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
    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
    LNH System, Nuclear Magnetic Resonance Imaging
    MOS Coil, Magnetic Resonance, Specialty

    GMDN Terms

    Code Name
    37652 Full-body MRI system, permanent magnet

    Identifiers

    Type ID
    Primary 00860006901110