BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tailback2-56

    DI: 00810113682716 · Model: TB056-2 · Manamed, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    3
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Tailback2-56
    Primary DI
    00810113682716
    Version / Model
    TB056-2
    Catalog Number
    TB056-2
    Company Name
    Manamed, Inc.
    Labeler DUNS
    084042331
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-19
    Public Version
    1
    Public Version Date
    2025-09-29
    Public Version Status
    New
    Public Device Record Key
    c9a53152-dce1-4ed5-8a17-829e863fa347

    Device Description

    The Tailback2-56 is a universal thoracic-lumbar-sacral orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Padded shoulder straps make applying the brace quick and easy. The thoracic extension telescopes to various heights to insure proper fits for all anatomy. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system

    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
    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
    IPT Orthosis, Thoracic

    GMDN Terms

    Code Name
    33031 Lumbar spine orthosis
    41042 Thoracic spine orthosis
    66086 Multiple spinal region orthosis

    Identifiers

    Type ID
    Primary 00810113682716