BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bio Leg™

    DI: 00860010894842 · Model: BLP001L · BIONICM INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bio Leg™
    Primary DI
    00860010894842
    Version / Model
    BLP001L
    Company Name
    BIONICM INC.
    Labeler DUNS
    717916018
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-21
    Public Version
    1
    Public Version Date
    2025-08-29
    Public Version Status
    New
    Public Device Record Key
    3f77ee1d-4e86-4381-9726-4883e6f5b9f0

    Device Description

    Large, black robotic prosthetic leg including knee joint, power cord, AC adapter, lower cover, instruction manual and other printed materials, for Loaner

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISW Assembly, Knee/Shank/Ankle/Foot, External

    GMDN Terms

    Code Name
    64721 Mechatronic external knee prosthesis

    Identifiers

    Type ID
    Primary 00860010894842