BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bausch + Lomb

    DI: 10757770060037 · Model: SE5427WVB · Bausch & Lomb Incorporated
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    Bausch + Lomb
    Primary DI
    10757770060037
    Version / Model
    SE5427WVB
    Catalog Number
    SE5427WVB
    Company Name
    Bausch & Lomb Incorporated
    Labeler DUNS
    196603781
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2021-06-23
    Public Version
    1
    Public Version Date
    2021-07-01
    Public Version Status
    New
    Public Device Record Key
    aec775d6-82af-4e1d-b576-e95e7f190480

    Device Description

    27 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    HQC Unit, Phacofragmentation
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

    GMDN Terms

    Code Name
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 10757770060037
    Unit of Use 00757770060030