BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Profile-ESP Bolster

    DI: 00868579000261 · Model: 3.0 · ORTHO KINEMATICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Profile-ESP Bolster
    Primary DI
    00868579000261
    Version / Model
    3.0
    Company Name
    ORTHO KINEMATICS, INC.
    Labeler DUNS
    932053221
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-14
    Public Version
    1
    Public Version Date
    2019-03-11
    Public Version Status
    New
    Public Device Record Key
    803652db-ebdf-43a3-9b6f-ec67596884d8

    Device Description

    The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).

    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
    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
    INW Table, Mechanical

    GMDN Terms

    Code Name
    40654 Basic diagnostic x-ray system table, non-powered

    Identifiers

    Type ID
    Primary 00868579000261