BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APEX Knee System

    DI: 00841690128939 · Model: KP-43101 · Omni Life Science, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APEX Knee System
    Primary DI
    00841690128939
    Version / Model
    KP-43101
    Catalog Number
    KP-43101
    Company Name
    Omni Life Science, Inc.
    Labeler DUNS
    061339651
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-19
    Public Version
    4
    Public Version Date
    2023-02-03
    Public Version Status
    Update
    Public Device Record Key
    f3da043b-312b-4f16-b0bb-fd3ae6122da8

    Device Description

    Femoral Augment, Notched Posterior, Size 3+, 10mm

    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
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

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

    GMDN Terms

    Code Name
    48067 Knee arthroplasty wedge

    Identifiers

    Type ID
    Primary 00841690128939

    Customer Contacts

    Phone
    +1(800)448-6664
    Email
    [email protected]