BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Doctor Smile / Doctor Diode Laser

    DI: 08056093611090 · Model: Protective eye wear · LAMBDA SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Doctor Smile / Doctor Diode Laser
    Primary DI
    08056093611090
    Version / Model
    Protective eye wear
    Catalog Number
    LOEYW002.0
    Company Name
    LAMBDA SPA
    Labeler DUNS
    428482616
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    fb6047db-df1e-48f3-b420-5fb1178b6029

    Device Description

    Eye protection (LOEYW002.0) against laser light at 980 nm

    Device Characteristics

    Single Use
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

    GMDN Terms

    Code Name
    36309 Laser beam eye protector, patient
    17650 Laser beam eye protector, staff

    Identifiers

    Type ID
    Primary 08056093611090

    Premarket Submissions

    Submission Number Supplement Number
    K091562 000
    K102036 000