BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Scleral Markers

    DI: 35056030402297 · Model: M7500-02/10 · STERIMEDIX LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    Scleral Markers
    Primary DI
    35056030402297
    Version / Model
    M7500-02/10
    Catalog Number
    M7500
    Company Name
    STERIMEDIX LIMITED
    Labeler DUNS
    504799313
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-10-07
    Public Version
    1
    Public Version Date
    2024-10-15
    Public Version Status
    New
    Public Device Record Key
    400bd163-d6b1-41a4-922e-3b785e04596c

    Device Description

    3.5 x 4mm Scleral Marker

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    MED Sterilant, Medical Devices

    GMDN Terms

    Code Name
    12442 Corneal marker, single-use

    Identifiers

    Type ID
    Unit of Use 25056030402290
    Primary 35056030402297