BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    RP X-OMAT LO Fixer and Replenisher

    DI: 60889978632664 · Model: RP X-OMAT LO Fixer and Replenisher · CARESTREAM HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RP X-OMAT LO Fixer and Replenisher
    Primary DI
    60889978632664
    Version / Model
    RP X-OMAT LO Fixer and Replenisher
    Catalog Number
    8632663
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2021-07-02
    Public Version Status
    Update
    Public Device Record Key
    b19d3812-8227-42d0-8cd1-4327a5f03e53
    Distribution End Date
    2021-06-29

    Device Description

    RP X-OMAT LO Fixer and Repl Part A 250GL

    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
    41008 X-ray film processing chemical, manual
    41009 X-ray film processing chemical, automatic

    Identifiers

    Type ID
    Primary 60889978632664