BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LiNA OperåScope™ Needle 4mm

    DI: 05708265012299 · Model: OP-NEE4-6 · Lina Medical ApS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LiNA OperåScope™ Needle 4mm
    Primary DI
    05708265012299
    Version / Model
    OP-NEE4-6
    Company Name
    Lina Medical ApS
    Labeler DUNS
    305088619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-03
    Public Version
    1
    Public Version Date
    2022-10-11
    Public Version Status
    New
    Public Device Record Key
    2b175dae-901e-4046-96d6-1118950a10e5

    Device Description

    LiNA OperåScope™ Needle 4mm, minimum channel diameter: Ø 2mm

    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
    No

    Product Codes

    Code Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology
    HIH Hysteroscope (And Accessories)

    GMDN Terms

    Code Name
    38825 General-purpose endoscopic needle, single-use

    Identifiers

    Type ID
    Package 05708265012305
    Primary 05708265012299

    Customer Contacts

    Phone
    +48612222149
    Email
    [email protected]