BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OtoLase™ Curved Tip

    DI: 07290109146805 · Model: OtoLase™ Curved Tip · LUMENIS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OtoLase™ Curved Tip
    Primary DI
    07290109146805
    Version / Model
    OtoLase™ Curved Tip
    Catalog Number
    SA-20055400
    Company Name
    LUMENIS LTD.
    Labeler DUNS
    600166524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-04
    Public Version
    1
    Public Version Date
    2022-09-12
    Public Version Status
    New
    Public Device Record Key
    ff32242b-7f93-4a3a-90ab-6b4b76e4dd41

    Device Description

    SA-20055400 Box: AC-20055390

    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    17774 General/multiple surgical solid-state/carbon dioxide laser system

    Identifiers

    Type ID
    Package 17290109146802
    Primary 07290109146805