BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    R3

    DI: 03596010600301 · Model: 71368748 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    R3
    Primary DI
    03596010600301
    Version / Model
    71368748
    Catalog Number
    71368748
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-30
    Public Version
    8
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    b3daddf3-7a88-473f-8f4f-35931536bb5d

    Device Description

    R3 20 DEGREE +4 28MM INNER DIAMETER TRIAL ACETABULAR 48MM OUTER DIAMETER

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    JDG Prosthesis, hip, femoral component, cemented, metal

    GMDN Terms

    Code Name
    58480 Acetabulum prosthesis trial, prefabricated, reusable

    Identifiers

    Type ID
    Primary 03596010600301

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K123598 000