BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR PHACO

    DI: G412PH94010 · Model: PH9401 · Crestpoint Management Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MR PHACO
    Primary DI
    G412PH94010
    Version / Model
    PH9401
    Company Name
    Crestpoint Management Limited
    Labeler DUNS
    836285668
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-27
    Public Version
    1
    Public Version Date
    2025-06-04
    Public Version Status
    New
    Public Device Record Key
    7e2559ba-c064-4490-a956-ed13fe22ba2b

    Device Description

    Lu-Mendez Degree Gauge Incision Guide Outside Diameter 18mm, Inside Diameter 13mm, Ruler markings on top of ring, Micro Teeth on Bottom inside of ring, Round Knurled Handle, 110mm Overall Length, Stainless Steel

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HOE Caliper, Ophthalmic

    GMDN Terms

    Code Name
    44796 Medical ruler, reusable

    Identifiers

    Type ID
    Primary G412PH94010