BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sgarlato Silastic

    DI: 00819034028610 · Model: 90-099-02 · 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
    00819034028610
    Version / Model
    90-099-02
    Catalog Number
    90-099-02
    Company Name
    FUSION ORTHOPEDICS, LLC
    Labeler DUNS
    080307067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-20
    Public Version
    2
    Public Version Date
    2021-04-21
    Public Version Status
    Update
    Public Device Record Key
    5759a22f-c2b7-4d63-ab7f-73008aee6869

    Device Description

    Shaw Rod Sizer Regular

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

    Product Codes

    Code Name
    KWH Prosthesis, Toe, Constrained, Polymer

    GMDN Terms

    Code Name
    61246 Surgical implant/trial-implant/sizer holder, single-use

    Identifiers

    Type ID
    Primary 00819034028610