BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EVA15

    DI: 05391536920005 · Model: LAP300 · PALLIARE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EVA15
    Primary DI
    05391536920005
    Version / Model
    LAP300
    Company Name
    PALLIARE LIMITED
    Labeler DUNS
    985710055
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-11
    Public Version
    4
    Public Version Date
    2023-06-20
    Public Version Status
    Update
    Public Device Record Key
    a26b477f-742f-4f32-9a7c-0c9e6cb0fa51

    Device Description

    LAP300 Laparoscopic Insufflation Tubeset

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIF Insufflator, Laparoscopic

    GMDN Terms

    Code Name
    60738 Endoscopic insufflation tubing set, single-use

    Identifiers

    Type ID
    Package 05391536920012
    Primary 05391536920005

    Customer Contacts

    Phone
    7606963243
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K202799 000