BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Gyrus ACMI

    DI: 00821925040342 · Model: 890923 · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gyrus ACMI
    Primary DI
    00821925040342
    Version / Model
    890923
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-13
    Public Version
    4
    Public Version Date
    2023-09-14
    Public Version Status
    Update
    Public Device Record Key
    4b1c6846-6bd8-4153-a461-fb9af60759df
    Distribution End Date
    2018-10-02

    Device Description

    STANDARD BALLOON CATHETER SILICONE

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EMX BALLOON, EPISTAXIS

    GMDN Terms

    Code Name
    48140 Nasal/paranasal balloon catheter

    Identifiers

    Type ID
    Package 00821925022355
    Primary 00821925040342