BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ingen SEVIIN® Shoulder System

    DI: B59910640000 · Model: 106-40-00 · INGEN ORTHOPEDICS, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ingen SEVIIN® Shoulder System
    Primary DI
    B59910640000
    Version / Model
    106-40-00
    Catalog Number
    106-40-00
    Company Name
    INGEN ORTHOPEDICS, L.L.C.
    Labeler DUNS
    187232066
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-20
    Public Version
    1
    Public Version Date
    2019-03-28
    Public Version Status
    New
    Public Device Record Key
    7aad5e87-d957-4806-bda9-7cd3cf9d88c0

    Device Description

    REVERSE GLENOSPHERE, 40MM DIA, STANDARD

    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 B59910640000

    Premarket Submissions

    Submission Number Supplement Number
    K120374 000