BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Surgi-Sign

    DI: G047SMSEYE1 · Model: 1 · Or-6, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Surgi-Sign
    Primary DI
    G047SMSEYE1
    Version / Model
    1
    Catalog Number
    SMS-Eye
    Company Name
    Or-6, LLC
    Labeler DUNS
    033826164
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2021-02-27
    Public Version
    1
    Public Version Date
    2021-03-08
    Public Version Status
    New
    Public Device Record Key
    f48ca49c-67c9-4f0f-81d9-b238a8b4642c

    Device Description

    A temporary tattoo that helps healthcare providers mark and confirm the correct operative site before the procedure. For more information please visit www.surgisign.com

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    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
    FZZ Marker, Skin

    GMDN Terms

    Code Name
    61577 Skin marking sticker

    Identifiers

    Type ID
    Unit of Use G047SMSEYE0
    Primary G047SMSEYE1