BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LiNA Xcise™, Laparoscopic Morcellator

    DI: 05708265004508 · Model: MOR-1515-1 · Lina Medical ApS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LiNA Xcise™, Laparoscopic Morcellator
    Primary DI
    05708265004508
    Version / Model
    MOR-1515-1
    Catalog Number
    MOR-1515-1
    Company Name
    Lina Medical ApS
    Labeler DUNS
    305088619
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    3
    Public Version Date
    2020-12-03
    Public Version Status
    Update
    Public Device Record Key
    40fa219c-1574-4332-89e9-5193af218c7e

    Device Description

    15mm battery powered morcellator system with obturator

    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
    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
    No

    Product Codes

    Code Name
    HET Laparoscope, Gynecologic (And Accessories)

    GMDN Terms

    Code Name
    64199 Tissue morcellation system handpiece, battery-powered

    Identifiers

    Type ID
    Package 05708265004515
    Primary 05708265004508

    Customer Contacts

    Phone
    +48612222121
    Email
    [email protected]