BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Back Brace

    DI: 06974500613432 · Model: JP03A01 · GCMEDICA ENTERPRISE LTD.(WUXI)
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Back Brace
    Primary DI
    06974500613432
    Version / Model
    JP03A01
    Company Name
    GCMEDICA ENTERPRISE LTD.(WUXI)
    Labeler DUNS
    560122957
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-08
    Public Version
    1
    Public Version Date
    2025-12-16
    Public Version Status
    New
    Public Device Record Key
    262932a8-93fb-4ae5-a4de-52f9e1ad74a5

    Device Description

    Adjustable Fiber Contents: Black mesh:100% polyester Black elastic band: 87.9% polyester 12.1% Spandex

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    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
    IPY Orthosis, Lumbo-Sacral

    GMDN Terms

    Code Name
    33031 Lumbar spine orthosis

    Identifiers

    Type ID
    Package 16974500613439
    Primary 06974500613432