BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DMX System

    DI: 00858340006158 · Model: DM-OTC18S · Del Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DMX System
    Primary DI
    00858340006158
    Version / Model
    DM-OTC18S
    Company Name
    Del Medical, Inc.
    Labeler DUNS
    078671236
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-15
    Public Version
    1
    Public Version Date
    2022-04-25
    Public Version Status
    New
    Public Device Record Key
    bed999d7-2af1-4286-a404-9dfa8f52c0fd

    Device Description

    The DM-OTC18S is a version of the DMX x-ray system which allows for stitching and tracking. This system can perform a comprehensive range of radiographic procedures.

    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
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPR System, X-Ray, Stationary

    GMDN Terms

    Code Name
    37645 Stationary basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 00858340006158