BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PVA Foam Surgical Spear

    DI: 00845819005866 · Model: B-0525 · OASIS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PVA Foam Surgical Spear
    Primary DI
    00845819005866
    Version / Model
    B-0525
    Company Name
    OASIS MEDICAL, INC.
    Labeler DUNS
    194121018
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    48778653-faf1-4d3e-9f60-880903d05f0f

    Device Description

    PVA Foam Surgical 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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    Primary 00845819005866
    Package 30845819005867
    Package 10845819005863
    Package 20845819005860

    Customer Contacts

    Phone
    9093055400
    Email
    [email protected]