BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Instruments

    DI: 00845819000755 · Model: 4004F, B-4004F · OASIS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disposable Instruments
    Primary DI
    00845819000755
    Version / Model
    4004F, B-4004F
    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
    ab021490-203e-4d7d-8bd6-a23d879d3b15

    Device Description

    Peribulbar Needle (Atkinson Point), 23g x 1-1/4" (0.64 x 32mm)

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    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 10845819000752
    Primary 00845819000755
    Package 20845819000759

    Customer Contacts

    Phone
    9093055400
    Email
    [email protected]