BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Dynamic Femur Fracture Brace

    DI: 00840194462815 · Model: NS-DF2B-0001 · ORTHOPEDIATRICS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dynamic Femur Fracture Brace
    Primary DI
    00840194462815
    Version / Model
    NS-DF2B-0001
    Catalog Number
    NS-DF2B-0001
    Company Name
    ORTHOPEDIATRICS CORP.
    Labeler DUNS
    796416191
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-25
    Public Version
    2
    Public Version Date
    2023-11-15
    Public Version Status
    Update
    Public Device Record Key
    33bc4f7a-67b5-4e7f-95d8-8451aa2d9e52
    Distribution End Date
    2023-06-25

    Device Description

    XS DF2 Femur Fracture Brace, Left, Static Knee

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IQI ORTHOSIS, LIMB BRACE

    GMDN Terms

    Code Name
    66085 Multiple-joint lower limb orthosis

    Identifiers

    Type ID
    Primary 00840194462815