BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    LF

    DI: 10746190002468 · Model: 700559 · Liebel-Flarsheim Company LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LF
    Primary DI
    10746190002468
    Version / Model
    700559
    Company Name
    Liebel-Flarsheim Company LLC
    Labeler DUNS
    080186051
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    6
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    051dc9db-bef2-4cf7-9372-95889f533e07
    Distribution End Date
    2019-10-11

    Device Description

    Direct Digital Urology Imaging System, 64kW

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    37633 Stationary uro-gynaecological fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 10746190002468

    Premarket Submissions

    Submission Number Supplement Number
    K121838 000