BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LAVA-18, 2 mL

    DI: 00850055697003 · Model: SLLES182 · Blackswan Vascular, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LAVA-18, 2 mL
    Primary DI
    00850055697003
    Version / Model
    SLLES182
    Company Name
    Blackswan Vascular, Inc.
    Labeler DUNS
    111242823
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-23
    Public Version
    3
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    0ec3f928-dc77-4731-b94d-1621eeec6048

    Device Description

    LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL

    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
    MR Conditional
    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
    QVG Embolization Agent, Vascular

    GMDN Terms

    Code Name
    67002 Non-neurovascular embolization plug, synthetic polymer

    Identifiers

    Type ID
    Primary 00850055697003

    Customer Contacts

    Phone
    1-888-474-7839
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P220020 000