BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MegaBeam® Endo-ENT Probe

    DI: 04049089100313 · Model: MegaBeam® Endo-ENT Probe, 24Ga, COH-H, noID · Ceram Optec SIA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MegaBeam® Endo-ENT Probe
    Primary DI
    04049089100313
    Version / Model
    MegaBeam® Endo-ENT Probe, 24Ga, COH-H, noID
    Catalog Number
    ENT-24-COH-H
    Company Name
    Ceram Optec SIA
    Labeler DUNS
    506069240
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-07
    Public Version
    5
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    b80b5e32-3347-4b4e-a401-5fc47cc5e4fd

    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
    62600 General/multiple surgical laser system beam guide, single-use

    Identifiers

    Type ID
    Package 04049089300317
    Package 04049089200310
    Primary 04049089100313