BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORE

    DI: 00860010346921 · Model: PKG-90-AOI-000020 · Swami Medical, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORE
    Primary DI
    00860010346921
    Version / Model
    PKG-90-AOI-000020
    Company Name
    Swami Medical, LLC
    Labeler DUNS
    119319166
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-22
    Public Version
    1
    Public Version Date
    2024-08-30
    Public Version Status
    New
    Public Device Record Key
    97aa3bbb-d8ec-4a05-8595-23fb0e1a6fbf

    Device Description

    OCA Single-Use Instrumentation Set, 20mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    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
    QBO Instruments Designed For Press-Fit Osteochondral Implants

    GMDN Terms

    Code Name
    56640 Orthopaedic implant-instrument extension adaptor, single-use

    Identifiers

    Type ID
    Primary 00860010346921