BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMTAI

    DI: 00811889030398 · Model: ACC0036 · AMTAI MEDICAL EQUIPMENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMTAI
    Primary DI
    00811889030398
    Version / Model
    ACC0036
    Company Name
    AMTAI MEDICAL EQUIPMENT, INC.
    Labeler DUNS
    830186198
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-06
    Public Version
    1
    Public Version Date
    2018-08-06
    Public Version Status
    New
    Public Device Record Key
    a1aef5ee-fc82-4b93-b2a5-b3b241669684

    Device Description

    Ophthalmic Headrest with Surgeon Wrist Support

    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
    No

    Product Codes

    Code Name
    FQO Table, Operating-Room, Ac-Powered

    GMDN Terms

    Code Name
    35379 Universal operating table, electrohydraulic

    Identifiers

    Type ID
    Primary 00811889030398