BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lantern Surgical Assistant (LSA)

    DI: 00810832031444 · Model: 406000-01 · ORTHALIGN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lantern Surgical Assistant (LSA)
    Primary DI
    00810832031444
    Version / Model
    406000-01
    Catalog Number
    406000-01
    Company Name
    ORTHALIGN, INC.
    Labeler DUNS
    023266163
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-27
    Public Version
    2
    Public Version Date
    2022-03-21
    Public Version Status
    Update
    Public Device Record Key
    c6ac4b35-b473-49ad-ae25-dcfc6cc6f7b6

    Device Description

    Packaged Assembly, Navigation Unit, LSA Knee

    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
    Yes
    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
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    45200 Orthopaedic stereotactic surgery system

    Identifiers

    Type ID
    Primary 00810832031444

    Customer Contacts

    Phone
    866-582-0879
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -22 – 140 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    -22 – 140 Degrees Fahrenheit