BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COMPRESSION PADDLE

    DI: 00843696114312 · Model: 14107 · Flow X Ray Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COMPRESSION PADDLE
    Primary DI
    00843696114312
    Version / Model
    14107
    Company Name
    Flow X Ray Corporation
    Labeler DUNS
    010016319
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-22
    Public Version
    3
    Public Version Date
    2024-02-27
    Public Version Status
    Update
    Public Device Record Key
    cb9f594d-4711-4707-b943-80cf233c9e62

    Device Description

    Designed for applying compression during G.I. series, our Wolf Compression Paddle is ideal for displacing barium, deflecting an intestinal loop, or applying compression for similar reasons. The Paddle features a rubber compression bladder, easily inflated by means of a built-in baumanometer bulb. A metal circle in the bladder ring fluoroscopically indicates the area under compression.

    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
    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
    HWN Instrument, Compression

    GMDN Terms

    Code Name
    66669 Radiological inflatable compression paddle

    Identifiers

    Type ID
    Primary 00843696114312