BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR PHACO

    DI: G412H200510 · Model: H2005-1 · 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
    G412H200510
    Version / Model
    H2005-1
    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
    546d4836-f129-4ca1-9ad3-85a55cb209b5

    Device Description

    Mackool/Cylindrical Spatula DBL-Ended with Short Handle, Mackool Phaco Chopper, Micro .38mm Ball Shaped Blunt tip with Interior Cutting Edge, Angled 10mm from bend to tip, / Cylindrical Spatula, .4 Blade Angled/Semi-Vaulted 11mm from bend to tip, Round Knurled Handle, 100mm 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
    HND Spatula, Ophthalmic

    GMDN Terms

    Code Name
    39610 General-purpose surgical spatula

    Identifiers

    Type ID
    Primary G412H200510