BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LINK Embrace Shoulder System

    DI: 04026575285853 · Model: 645-077/20 · WALDEMAR LINK GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LINK Embrace Shoulder System
    Primary DI
    04026575285853
    Version / Model
    645-077/20
    Catalog Number
    645-077/20
    Company Name
    WALDEMAR LINK GmbH & Co. KG
    Labeler DUNS
    315675488
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-24
    Public Version
    2
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    a1d1637f-0abe-444f-92e0-a64b24d37fb9

    Device Description

    Bone Screws, and Central Cancellous Bone Screw, Ce

    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
    Yes
    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
    PHX shoulder prosthesis, reverse configuration
    HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
    PAO prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

    GMDN Terms

    Code Name
    48094 Shoulder prosthesis screw

    Identifiers

    Type ID
    Primary 04026575285853

    Premarket Submissions

    Submission Number Supplement Number
    K200368 000