BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stat-A-Dyne ESP

    DI: B770ES0 · Model: ESP · LANTZ MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Stat-A-Dyne ESP
    Primary DI
    B770ES0
    Version / Model
    ESP
    Catalog Number
    ESP
    Company Name
    LANTZ MEDICAL, INC.
    Labeler DUNS
    614335276
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    1f36164f-9165-431f-b801-784b9a4331be

    Device Description

    Orthosis providing flexion, extension, pronation, and supination of elbow

    Device Characteristics

    Single Use
    No
    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
    IQI Orthosis, Limb Brace

    GMDN Terms

    Code Name
    41466 Multiple-joint arm orthosis

    Identifiers

    Type ID
    Primary B770ES0