BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vantage PSI

    DI: 00816847022576 · Model: Talus Cutting Guide · 3D SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vantage PSI
    Primary DI
    00816847022576
    Version / Model
    Talus Cutting Guide
    Catalog Number
    351-80-00
    Company Name
    3D SYSTEMS, INC.
    Labeler DUNS
    085049749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-13
    Public Version
    2
    Public Version Date
    2023-08-30
    Public Version Status
    Update
    Public Device Record Key
    a6eea775-6a66-467c-b90d-59215b3901be

    Device Description

    A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

    Device Characteristics

    Single Use
    No
    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 Unsafe
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    OYK Ankle Arthroplasty Implantation System

    GMDN Terms

    Code Name
    61917 Osteotomy guide, reusable

    Identifiers

    Type ID
    Primary 00816847022576

    Customer Contacts

    Phone
    8446431001
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K193432 000

    Device Sizes

    Type Value Unit Text
    Length 25 Millimeter