BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mediflex Laparoscopic Instruments - Suture Grasper Guides

    DI: 00842102112331 · Model: 94415 · FLEXBAR MACHINE CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mediflex Laparoscopic Instruments - Suture Grasper Guides
    Primary DI
    00842102112331
    Version / Model
    94415
    Company Name
    FLEXBAR MACHINE CORPORATION
    Labeler DUNS
    047644935
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-31
    Public Version
    1
    Public Version Date
    2019-03-04
    Public Version Status
    New
    Public Device Record Key
    a68d8efe-0a82-49be-b100-432381c277a1

    Device Description

    Suture Passer Guide, 10mm x 11.2cm

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    FZX Guide, Surgical, Instrument

    GMDN Terms

    Code Name
    36129 Suturing guide

    Identifiers

    Type ID
    Primary 00842102112331