BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ti-MESH

    DI: 04042301117397 · Model: 6000471 · pfm medical titanium gmbh
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ti-MESH
    Primary DI
    04042301117397
    Version / Model
    6000471
    Company Name
    pfm medical titanium gmbh
    Labeler DUNS
    344675942
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-01
    Public Version
    3
    Public Version Date
    2022-11-14
    Public Version Status
    Update
    Public Device Record Key
    d941678f-73b2-491d-b759-2d3970b5066f

    Device Description

    Ti-MESH 6" X 6"Strong 65g/m²

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FTL Mesh, Surgical, Polymeric
    OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

    GMDN Terms

    Code Name
    44756 Extra-gynaecological surgical mesh, composite-polymer

    Identifiers

    Type ID
    Package 04042301137173
    Primary 04042301117397

    Customer Contacts

    Phone
    7607588749
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K031225 000