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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Holep Kit with SIS fiber for Versacut+

    DI: 07290109141992 · Model: Holep Kit with SIS fiber for Versacut+ · LUMENIS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Holep Kit with SIS fiber for Versacut+
    Primary DI
    07290109141992
    Version / Model
    Holep Kit with SIS fiber for Versacut+
    Company Name
    LUMENIS LTD.
    Labeler DUNS
    600166524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-30
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    75ca5a23-6700-4183-9d03-922c5f8e4634

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    36170 General/multiple surgical solid-state laser system

    Identifiers

    Type ID
    Primary 07290109141992

    Customer Contacts

    Phone
    408-764-3000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K133272 000