BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LASIK Spear

    DI: 00813465011340 · Model: 7306 · HURRICANE MEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    15

    Basic Information

    Brand Name
    LASIK Spear
    Primary DI
    00813465011340
    Version / Model
    7306
    Catalog Number
    7306
    Company Name
    HURRICANE MEDICAL INC
    Labeler DUNS
    093377724
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    15
    Record Status
    Published
    Publish Date
    2016-04-26
    Public Version
    5
    Public Version Date
    2020-04-14
    Public Version Status
    Update
    Public Device Record Key
    70acd28f-60e2-49c9-a707-e6547975e8ba

    Device Description

    This device is used during LASIK surgical procedures to manipulate eye tissue and remove surgical fluid and debris.

    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
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    HOZ Sponge, Ophthalmic

    GMDN Terms

    Code Name
    13704 Ophthalmic sponge

    Identifiers

    Type ID
    Primary 00813465011340
    Unit of Use 10813465011347

    Customer Contacts

    Phone
    9417510588
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K990671 000