BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    I-KNIFE

    DI: 00380654015019 · Model: 8065401501 · Alcon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    I-KNIFE
    Primary DI
    00380654015019
    Version / Model
    8065401501
    Company Name
    Alcon Laboratories, Inc.
    Labeler DUNS
    008018525
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-18
    Public Version
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    5090dbe2-3c33-4927-b3b1-c704c96f2ae1

    Device Description

    I-KNIFE Cutting Instrument 15 degree

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HNN Knife, ophthalmic

    GMDN Terms

    Code Name
    46741 Ophthalmic knife, single-use

    Identifiers

    Type ID
    Package 10380654015016
    Primary 00380654015019

    Customer Contacts

    Phone
    +1(800)862-5266
    Email
    [email protected]