BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Persona® Partial Knee System

    DI: 00880304812697 · Model: 42-5380-005-02 · Biomet Orthopedics, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Persona® Partial Knee System
    Primary DI
    00880304812697
    Version / Model
    42-5380-005-02
    Catalog Number
    42-5380-005-02
    Company Name
    Biomet Orthopedics, LLC
    Labeler DUNS
    129278169
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-29
    Public Version
    5
    Public Version Date
    2022-02-09
    Public Version Status
    Update
    Public Device Record Key
    004c47ad-5392-46cf-a491-9ec2b58597a3

    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 Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

    GMDN Terms

    Code Name
    48068 Uncoated unicondylar knee tibia prosthesis, metallic

    Identifiers

    Type ID
    Primary 00880304812697

    Customer Contacts

    Phone
    +1(800)348-9500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K161592 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Size E RIGHT Medial