BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KineMatch® PFR System

    DI: 00818720011301 · Model: Custom 265 · Kinamed, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KineMatch® PFR System
    Primary DI
    00818720011301
    Version / Model
    Custom 265
    Catalog Number
    Custom 265
    Company Name
    Kinamed, Inc.
    Labeler DUNS
    184896645
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    c94b7897-a9cd-4521-abf9-fcaa3374be78

    Device Description

    CUSTOM PFR TRIAL IMPLANT LEFT

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    44052 Orthopaedic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00818720011301