BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-OMAT EX II Developer and Replenisher

    DI: 60889975274393 · Model: X-OMAT EX II Developer and Replenisher · CARESTREAM HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-OMAT EX II Developer and Replenisher
    Primary DI
    60889975274393
    Version / Model
    X-OMAT EX II Developer and Replenisher
    Catalog Number
    5274394
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-26
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    805b9f8a-4284-45d1-9c14-9ccf2cde7d79

    Device Description

    X-OMAT EX II DEVELOPER AND REPL 2 X 20L

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IWZ Film, radiographic

    GMDN Terms

    Code Name
    41009 X-ray film processing chemical, automatic

    Identifiers

    Type ID
    Primary 60889975274393