BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Veritas rTSA

    DI: 00840097515625 · Model: 1501-4001 · Restor3d, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Veritas rTSA
    Primary DI
    00840097515625
    Version / Model
    1501-4001
    Company Name
    Restor3d, Inc.
    Labeler DUNS
    080819836
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-25
    Public Version
    1
    Public Version Date
    2025-09-02
    Public Version Status
    New
    Public Device Record Key
    c297f39a-b949-4a8e-84db-a36d03739fd6

    Device Description

    CoCr Glenosphere w/ Ti Security Screw, 40mm, +0mm

    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

    GMDN Terms

    Code Name
    48093 Reverse shoulder prosthesis head

    Identifiers

    Type ID
    Primary 00840097515625

    Premarket Submissions

    Submission Number Supplement Number
    K243643 000