BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trulife

    DI: 00645517327082 · Model: JS-1528 · TRULIFE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trulife
    Primary DI
    00645517327082
    Version / Model
    JS-1528
    Company Name
    TRULIFE LIMITED
    Labeler DUNS
    289728891
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-31
    Public Version
    2
    Public Version Date
    2023-06-07
    Public Version Status
    Update
    Public Device Record Key
    9acf3087-ce1a-47b9-aa79-9a7c05e9e9a1

    Device Description

    OVER SHOULDER HUMERAL FX XL L

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    44878 Shoulder immobilizer/orthosis, single-use

    Identifiers

    Type ID
    Primary 00645517327082