BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TC-PLUS

    DI: 07611996009064 · Model: 75006064 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TC-PLUS
    Primary DI
    07611996009064
    Version / Model
    75006064
    Catalog Number
    75006064
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-13
    Public Version
    5
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    5c8dab53-644d-4bfd-b254-cc913b52ea79

    Device Description

    TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRACONGRUENT 12/15

    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
    No
    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
    No

    Product Codes

    Code Name
    JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    GMDN Terms

    Code Name
    33580 Uncoated knee tibia prosthesis, polyethylene

    Identifiers

    Type ID
    Primary 07611996009064

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K000666 000