BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LAP-13-4

    DI: 00842102105081 · Model: D1005 · FLEXBAR MACHINE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LAP-13-4
    Primary DI
    00842102105081
    Version / Model
    D1005
    Catalog Number
    D1005
    Company Name
    FLEXBAR MACHINE CORPORATION
    Labeler DUNS
    047644935
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-11
    Public Version
    3
    Public Version Date
    2020-11-19
    Public Version Status
    Update
    Public Device Record Key
    d7c1d5ac-2a00-4f18-98c7-b37aee49883c

    Device Description

    Cholangiography Catheter, Port Insertion

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    GBZ Catheter, Cholangiography

    GMDN Terms

    Code Name
    16429 ERCP catheter, non-balloon, non-electrical, single-use

    Identifiers

    Type ID
    Package 10842102105088
    Primary 00842102105081