BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TenoTrap (7mm x12mm Tenodesis Screw)

    DI: 00850052601003 · Model: AB-6401 · DUNAMIS MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TenoTrap (7mm x12mm Tenodesis Screw)
    Primary DI
    00850052601003
    Version / Model
    AB-6401
    Catalog Number
    AB-6401
    Company Name
    DUNAMIS MEDICAL, LLC
    Labeler DUNS
    079471560
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-11
    Public Version
    2
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    828db44d-ef0b-4a96-a0d1-8a52dd0dba11

    Device Description

    TenoTrap (AB-6401) (7mm x12mm Tenodesis Screw)

    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
    MR Safe
    Direct Marking Exempt
    Yes
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    GMDN Terms

    Code Name
    46646 Orthopaedic bone screw, non-bioabsorbable, sterile

    Identifiers

    Type ID
    Primary 00850052601003