BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anodyne Surgical

    DI: 00840516114644 · Model: 0003H · Psi/Eye-Ko, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anodyne Surgical
    Primary DI
    00840516114644
    Version / Model
    0003H
    Company Name
    Psi/Eye-Ko, Inc.
    Labeler DUNS
    063763833
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-28
    Public Version
    1
    Public Version Date
    2023-09-05
    Public Version Status
    New
    Public Device Record Key
    e2d60d74-f8a6-4ccd-969e-29d01e2decaa

    Device Description

    Retrobulbar Needle [Atkinson] 25g X 38mm (1 1/2")

    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
    Yes
    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
    ["Ethylene Oxide", "Radiation Sterilization"]

    Product Codes

    Code Name
    GAA Needle, Aspiration And Injection, Disposable

    GMDN Terms

    Code Name
    47610 Ophthalmic needle, single-use

    Identifiers

    Type ID
    Package 00840516118574
    Primary 00840516114644
    Package 00840516122441

    Customer Contacts

    Phone
    1(800)428-5628
    Email
    [email protected]