BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPTIMAX 2010

    DI: 04260502640036 · Model: 1160 · PROTEC GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPTIMAX 2010
    Primary DI
    04260502640036
    Version / Model
    1160
    Catalog Number
    1160-9-8000
    Company Name
    PROTEC GmbH & Co. KG
    Labeler DUNS
    314629130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-28
    Public Version
    3
    Public Version Date
    2019-12-17
    Public Version Status
    Update
    Public Device Record Key
    a6ecb4f5-9b51-4329-943f-bb17761dc049

    Device Description

    Darkroom automated x-ray film processor

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IXW Processor, Radiographic-Film, Automatic

    GMDN Terms

    Code Name
    41011 Darkroom automated x-ray film processor

    Identifiers

    Type ID
    Primary 04260502640036

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    50 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    18 – 40 Degrees Celsius