BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Henry Schein

    DI: 00304040005194 · Model: 1126977 · HENRY SCHEIN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Henry Schein
    Primary DI
    00304040005194
    Version / Model
    1126977
    Catalog Number
    1126977
    Company Name
    HENRY SCHEIN, INC.
    Labeler DUNS
    012430880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    4
    Public Version Date
    2023-10-16
    Public Version Status
    Update
    Public Device Record Key
    8720a45f-df25-4b3e-be08-9a56c5610c68

    Device Description

    Maxicide OPA 28 Test Strips

    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
    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
    46945 Ortho-phthalaldehyde (OPA) device disinfectant test strip

    Identifiers

    Type ID
    Package 20304040005198
    Primary 00304040005194
    Unit of Use 10304040005191