BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GemcisionTM Keratome Lancet, Super Sharp, Sharp Sides, 2.4mm Width

    DI: 00840096201246 · Model: 7924-K24 · KATALYST SURGICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GemcisionTM Keratome Lancet, Super Sharp, Sharp Sides, 2.4mm Width
    Primary DI
    00840096201246
    Version / Model
    7924-K24
    Company Name
    KATALYST SURGICAL LLC
    Labeler DUNS
    007883297
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-19
    Public Version
    2
    Public Version Date
    2022-12-09
    Public Version Status
    Update
    Public Device Record Key
    ee85cf1f-6747-4d47-b21b-2e51e0f0eb6f

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HNN Knife, Ophthalmic

    GMDN Terms

    Code Name
    32764 Ophthalmic knife, reusable

    Identifiers

    Type ID
    Primary 00840096201246
    Package 10840096201243