BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NA

    DI: 03596010196415 · Model: 71322638 · Smith & Nephew, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    03596010196415
    Version / Model
    71322638
    Catalog Number
    71322638
    Company Name
    Smith & Nephew, Inc.
    Labeler DUNS
    045483575
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-30
    Public Version
    6
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    4e0bccde-ca3c-4cc9-99f4-df0583bb4b7b
    Distribution End Date
    2022-03-17

    Device Description

    universal bipolar liner 26mmid 38-42mmod

    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
    KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

    GMDN Terms

    Code Name
    33695 Bipolar femoral head outer component, hemiarthroplasty

    Identifiers

    Type ID
    Primary 03596010196415

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K823726 000