BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SMR Shoulder

    DI: 08033390099936 · Model: Trial Stem · LIMACORPORATE SPA
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SMR Shoulder
    Primary DI
    08033390099936
    Version / Model
    Trial Stem
    Catalog Number
    9013.02.181
    Company Name
    LIMACORPORATE SPA
    Labeler DUNS
    432066322
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-02
    Public Version
    5
    Public Version Date
    2022-07-04
    Public Version Status
    Update
    Public Device Record Key
    40bb6282-844e-40c2-8031-4a5af619b31b

    Device Description

    Trial Stem with Quick Connection Dia.18 mm

    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
    HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

    GMDN Terms

    Code Name
    60936 Humeral stem prosthesis trial, reusable

    Identifiers

    Type ID
    Primary 08033390099936

    Premarket Submissions

    Submission Number Supplement Number
    K100858 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Dia. 18 mm