BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iTotal Identity CR

    DI: M572RCR0201600141 · Model: RCR020160014 · Conformis, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iTotal Identity CR
    Primary DI
    M572RCR0201600141
    Version / Model
    RCR020160014
    Catalog Number
    RCR-020-1600
    Company Name
    Conformis, Inc.
    Labeler DUNS
    808821883
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-07
    Public Version
    1
    Public Version Date
    2019-10-15
    Public Version Status
    New
    Public Device Record Key
    d9b24ea3-eb69-49e4-bae3-81eccf0561c5

    Device Description

    ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, MEDIAL, 16MM, LEFT & RIGHT

    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
    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
    OOG Knee Arthroplasty Implantation System
    OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

    GMDN Terms

    Code Name
    46585 Tibial insert

    Identifiers

    Type ID
    Primary M572RCR0201600141

    Customer Contacts

    Phone
    781-345-9001
    Email
    [email protected]