BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Accu-Beam

    DI: B17720502311 · Model: 205-023-1 · TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Accu-Beam
    Primary DI
    B17720502311
    Version / Model
    205-023-1
    Company Name
    TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
    Labeler DUNS
    130213366
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-10-05
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    cd7e994c-9d06-463e-9c21-70bf6dc5547c
    Distribution End Date
    2022-06-28

    Device Description

    10x Silicone gripper for 16ga fiberoptic handpiece.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    61474 General/multiple surgical laser system beam guide, reusable

    Identifiers

    Type ID
    Primary B17720502311
    Unit of Use B177205023100

    Premarket Submissions

    Submission Number Supplement Number
    K952006 000