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    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR PHACO

    DI: G412PH90300 · Model: PH9030 · Crestpoint Management Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MR PHACO
    Primary DI
    G412PH90300
    Version / Model
    PH9030
    Company Name
    Crestpoint Management Limited
    Labeler DUNS
    836285668
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-07
    Public Version
    1
    Public Version Date
    2025-06-16
    Public Version Status
    New
    Public Device Record Key
    098364ea-3b2c-4bc6-851f-6f7ff8209fbf

    Device Description

    Alphonso Eye Speculum Newborn, .035 Stainless Wire, 5mm Closed Square Blade slides inside 8mm Closed Square Blade, Dull Finish on Disk, 27mm Blade Spread, 45mm Overall Length

    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
    HNC Specula, Ophthalmic

    GMDN Terms

    Code Name
    35010 Lacrimal dilator, reusable

    Identifiers

    Type ID
    Primary G412PH90300