BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Duckworth & Kent

    DI: 05055313818922 · Model: DK7797-3 · DUCKWORTH AND KENT LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Duckworth & Kent
    Primary DI
    05055313818922
    Version / Model
    DK7797-3
    Catalog Number
    DK7797-3
    Company Name
    DUCKWORTH AND KENT LIMITED
    Labeler DUNS
    217182583
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-31
    Public Version
    3
    Public Version Date
    2023-08-21
    Public Version Status
    Update
    Public Device Record Key
    3aa0cd64-0107-43d3-80a2-fc70ae79c5b7

    Device Description

    IOL Injector

    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
    No
    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
    KYB Lens, Guide, Intraocular

    GMDN Terms

    Code Name
    47724 Manual intraocular lens injector, reusable

    Identifiers

    Type ID
    Primary 05055313818922

    Customer Contacts

    Phone
    +441462893254
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072985 000