BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    R1 Reverse Shoulder System

    DI: 00811596030537 · Model: 1230-7507-001 · CATALYST ORTHOSCIENCE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    R1 Reverse Shoulder System
    Primary DI
    00811596030537
    Version / Model
    1230-7507-001
    Company Name
    CATALYST ORTHOSCIENCE INC.
    Labeler DUNS
    079702565
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-28
    Public Version
    1
    Public Version Date
    2021-03-08
    Public Version Status
    New
    Public Device Record Key
    a6c3eca3-4025-4ef2-bf6c-e231f701501c

    Device Description

    Augmented Baseplate 10°

    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
    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
    33711 Total reverse shoulder prosthesis

    Identifiers

    Type ID
    Primary 00811596030537

    Customer Contacts

    Phone
    800-587-5137
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K202611 000