BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bausch + Lomb

    DI: 00757770520107 · Model: E9108 · Bausch & Lomb Incorporated
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bausch + Lomb
    Primary DI
    00757770520107
    Version / Model
    E9108
    Catalog Number
    E9108
    Company Name
    Bausch & Lomb Incorporated
    Labeler DUNS
    196603781
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-21
    Public Version
    1
    Public Version Date
    2024-11-29
    Public Version Status
    New
    Public Device Record Key
    a6711efa-b742-4232-99a0-faa537e195c1

    Device Description

    MACRAE LASEK OVAL WELL

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HMR Marker, Ocular

    GMDN Terms

    Code Name
    63523 LASEK alcohol well, reusable

    Identifiers

    Type ID
    Primary 00757770520107