BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gyrus ACMI

    DI: 00821925011663 · Model: 130070 · Gyrus ACMI, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Gyrus ACMI
    Primary DI
    00821925011663
    Version / Model
    130070
    Company Name
    Gyrus ACMI, LLC
    Labeler DUNS
    007198742
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-07
    Public Version
    4
    Public Version Date
    2024-09-02
    Public Version Status
    Update
    Public Device Record Key
    ccc2b8ff-3549-4777-b4be-bbe74a5207fa

    Device Description

    SPECULUM HOLDER

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    JYK Holder, Ear Speculum

    GMDN Terms

    Code Name
    33429 ENT speculum holder

    Identifiers

    Type ID
    Primary 00821925011663