BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    iUni® iPoly™ Insert Kit

    DI: M572RUK0100600011 · Model: RUK010060001 · Conformis, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iUni® iPoly™ Insert Kit
    Primary DI
    M572RUK0100600011
    Version / Model
    RUK010060001
    Catalog Number
    RUK0100600
    Company Name
    Conformis, Inc.
    Labeler DUNS
    808821883
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-26
    Public Version
    3
    Public Version Date
    2022-08-16
    Public Version Status
    Update
    Public Device Record Key
    6ff9d1eb-5a3f-4f8a-8192-fa80000c9069
    Distribution End Date
    2022-08-15

    Device Description

    N/A

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    OOG Knee Arthroplasty Implantation System

    GMDN Terms

    Code Name
    33369 Uncoated unicondylar knee femur prosthesis

    Identifiers

    Type ID
    Primary M572RUK0100600011

    Customer Contacts

    Phone
    781-345-9001
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Height 6 Millimeter