BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SteriTec Cross-Checks EO

    DI: 00814434020073 · Model: CI 106 · STERITEC PRODUCT MFG. CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SteriTec Cross-Checks EO
    Primary DI
    00814434020073
    Version / Model
    CI 106
    Catalog Number
    CI 106, CI 106/ITL
    Company Name
    STERITEC PRODUCT MFG. CO., INC.
    Labeler DUNS
    622223196
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    b7a91265-8c68-4a6a-bcd4-b1d51cdbf54d

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JOJ Indicator, Physical/Chemical Sterilization Process

    GMDN Terms

    Code Name
    35362 Chemical/physical sterilization process indicator

    Identifiers

    Type ID
    Package 40814434020071
    Package 30814434020074
    Primary 00814434020073
    Package 20814434020077
    Package 10814434020070

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    10 – 70 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 38 Degrees Celsius