BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DELTA XTEND

    DI: 10603295502500 · Model: 1307-62-142 · DEPUY (IRELAND)
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DELTA XTEND
    Primary DI
    10603295502500
    Version / Model
    1307-62-142
    Catalog Number
    130762142
    Company Name
    DEPUY (IRELAND)
    Labeler DUNS
    989365556
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-22
    Public Version
    2
    Public Version Date
    2021-02-15
    Public Version Status
    Update
    Public Device Record Key
    d1069f70-2544-4de3-92db-dbd7a641c46f

    Device Description

    DELTA XTEND Lateralized Glenosphere +2mm Standard 042mm

    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
    MR Conditional
    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
    PHX shoulder prosthesis, reverse configuration
    KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
    HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

    GMDN Terms

    Code Name
    33711 Total reverse shoulder prosthesis

    Identifiers

    Type ID
    Primary 10603295502500

    Customer Contacts

    Phone
    +1(800)255-2500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K183077 000
    K192855 000