BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anodyne Surgical

    DI: 00840516113708 · Model: FA01-0101-0520 · Psi/Eye-Ko, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    200

    Basic Information

    Brand Name
    Anodyne Surgical
    Primary DI
    00840516113708
    Version / Model
    FA01-0101-0520
    Company Name
    Psi/Eye-Ko, Inc.
    Labeler DUNS
    063763833
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    200
    Record Status
    Published
    Publish Date
    2023-06-26
    Public Version
    1
    Public Version Date
    2023-07-04
    Public Version Status
    New
    Public Device Record Key
    82f76008-6e7f-42b2-b9b1-c98fa561242c

    Device Description

    PVA Spear

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    HOZ Sponge, Ophthalmic

    GMDN Terms

    Code Name
    13704 Ophthalmic sponge

    Identifiers

    Type ID
    Unit of Use 00840516113692
    Primary 00840516113708

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K082460 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 37 Degrees Celsius