BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Paragon 28 Bone Wedge System

    DI: 00889795120632 · Model: AOLEW-22-12 · PARAGON 28, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Paragon 28 Bone Wedge System
    Primary DI
    00889795120632
    Version / Model
    AOLEW-22-12
    Catalog Number
    AOLEW-22-12
    Company Name
    PARAGON 28, INC.
    Labeler DUNS
    042961576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-04
    Public Version
    1
    Public Version Date
    2023-04-12
    Public Version Status
    New
    Public Device Record Key
    90638885-f942-4b8c-b723-d072ab850883

    Device Description

    AO LCKG EVANS BONE SEG 22 X 22 X 12

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HRS Plate, fixation, bone

    GMDN Terms

    Code Name
    61617 Metallic osteotomy fusion cage, non-customized

    Identifiers

    Type ID
    Primary 00889795120632