BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Loop-X Disposable Sterile Drape Set

    DI: 04056481143299 · Model: 22183-01 · Brainlab AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Loop-X Disposable Sterile Drape Set
    Primary DI
    04056481143299
    Version / Model
    22183-01
    Company Name
    Brainlab AG
    Labeler DUNS
    314482980
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-12
    Public Version
    2
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    1a298037-c977-4981-9026-43a3f342a893

    Device Description

    The Loop-X Disposable Sterile Drape Set is an accessory for the Loop-X imaging device. The drape set creates a sterile barrier between the OR field and the imaging device, allowing intraoperative 2D imaging of patients in a sterile environment.

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PUI Drape, Surgical, Exempt

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package 04056481142827
    Primary 04056481143299