BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Embrace Shoulder System

    DI: 04026575234400 · Model: 641-045/16 · WALDEMAR LINK GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Embrace Shoulder System
    Primary DI
    04026575234400
    Version / Model
    641-045/16
    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
    2023-01-26
    Public Version
    1
    Public Version Date
    2023-02-03
    Public Version Status
    New
    Public Device Record Key
    96a1bad8-5f21-437d-a782-bf43947e0c0f

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    60512 Shoulder humeral body prosthesis

    Identifiers

    Type ID
    Primary 04026575234400

    Premarket Submissions

    Submission Number Supplement Number
    K212992 000