BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Adaptable

    DI: 00860012987818 · Model: Adaptable Rail Extender · Quantum Ops, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Adaptable
    Primary DI
    00860012987818
    Version / Model
    Adaptable Rail Extender
    Catalog Number
    804-33-006
    Company Name
    Quantum Ops, Inc.
    Labeler DUNS
    036253884
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-02
    Public Version
    1
    Public Version Date
    2025-06-10
    Public Version Status
    New
    Public Device Record Key
    ecabe90c-8a4a-457c-9a46-8d8c6aed1322

    Device Description

    The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by extending the Rail of the Back Side of the T-Max to install the Adaptable Arm, achieving a complete exposure and mobility on the patient arm.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    BWN Table And Attachments, Operating-Room

    GMDN Terms

    Code Name
    37047 Arm procedure positioner, reusable

    Identifiers

    Type ID
    Primary 00860012987818