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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Triathlon

    DI: 07613327015232 · Model: 5541-A-402 · Howmedica Osteonics Corp.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Triathlon
    Primary DI
    07613327015232
    Version / Model
    5541-A-402
    Catalog Number
    5541-A-402
    Company Name
    Howmedica Osteonics Corp.
    Labeler DUNS
    058311945
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    4
    Public Version Date
    2023-02-03
    Public Version Status
    Update
    Public Device Record Key
    dc78a63b-d4a3-48ac-bf6a-e6eff859644c

    Device Description

    Femoral Distal Augment

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
    MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

    GMDN Terms

    Code Name
    48067 Knee arthroplasty wedge

    Identifiers

    Type ID
    Primary 07613327015232

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Side: RIGHT
    Device Size Text, specify Size: 4
    Device Size Text, specify Thickness: 10.0 Millimeter