BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgilum

    DI: B836RMS1010 · Model: RMS101 · Surgilum, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Surgilum
    Primary DI
    B836RMS1010
    Version / Model
    RMS101
    Catalog Number
    RMS101
    Company Name
    Surgilum, LLC
    Labeler DUNS
    079726409
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-01
    Public Version
    2
    Public Version Date
    2021-12-10
    Public Version Status
    Update
    Public Device Record Key
    11b2a96f-9c0c-4ed1-bfe6-de8059184a50

    Device Description

    A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it includes a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HMR Marker, Ocular

    GMDN Terms

    Code Name
    61740 Corneal marker handpiece

    Identifiers

    Type ID
    Primary B836RMS1010