BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Titan™

    DI: 10381780467700 · Model: SCW-0961-046-30 · Ascension Orthopedics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Titan™
    Primary DI
    10381780467700
    Version / Model
    SCW-0961-046-30
    Catalog Number
    SCW-0961-046-30
    Company Name
    Ascension Orthopedics, Inc.
    Labeler DUNS
    942377524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-05
    Public Version
    3
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    e9359128-b269-42fc-85c2-914a0f18c541
    Distribution End Date
    2026-12-31

    Device Description

    RSS 4.5mm Star Screw and Cap; 30mm Length

    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
    No
    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
    48094 Shoulder prosthesis screw

    Identifiers

    Type ID
    Primary 10381780467700

    Customer Contacts

    Phone
    +1(800)654-2873
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181999 000

    Device Sizes

    Type Value Unit Text
    Length 30 Millimeter