BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sgarlato Silastic

    DI: 00819034028535 · Model: 80-100-02 · FUSION ORTHOPEDICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sgarlato Silastic
    Primary DI
    00819034028535
    Version / Model
    80-100-02
    Catalog Number
    80-100-02
    Company Name
    FUSION ORTHOPEDICS, LLC
    Labeler DUNS
    080307067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-19
    Public Version
    2
    Public Version Date
    2021-04-21
    Public Version Status
    Update
    Public Device Record Key
    83f3860d-34db-464f-8b5e-244d37d18cb0

    Device Description

    SHIP Long Implant Flexible

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KWH Prosthesis, Toe, Constrained, Polymer

    GMDN Terms

    Code Name
    33700 Total metatarsophalangeal joint prosthesis, one-piece

    Identifiers

    Type ID
    Primary 00819034028535