BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UNFOLDER EMERALD

    DI: 15050474534503 · Model: EMERALDXL · JOHNSON & JOHNSON SURGICAL VISION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UNFOLDER EMERALD
    Primary DI
    15050474534503
    Version / Model
    EMERALDXL
    Catalog Number
    EMERALDXL
    Company Name
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Labeler DUNS
    103021940
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-13
    Public Version
    3
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    2bf65e8a-fbf4-4e9a-885e-8cc8d9878746

    Device Description

    MODEL EMERALDXL HANDPIECE, 690735

    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
    No
    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
    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 15050474534503

    Customer Contacts

    Phone
    +1(877)266-4543
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K961242 000