BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accu-Beam

    DI: B1778020I0 · Model: 8020I · TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accu-Beam
    Primary DI
    B1778020I0
    Version / Model
    8020I
    Company Name
    TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
    Labeler DUNS
    130213366
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-29
    Public Version
    3
    Public Version Date
    2021-08-13
    Public Version Status
    Update
    Public Device Record Key
    aed4a8f9-9de7-49fe-906f-f97b33fdc1cf

    Device Description

    22.5mm-50mm parfocal Zoom Endoscopic Coupler. Insulated.

    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
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    FWL Camera, Cine, Endoscopic, Without Audio

    GMDN Terms

    Code Name
    36292 Endoscope camera adaptor

    Identifiers

    Type ID
    Primary B1778020I0