BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CRH O'Regan System

    DI: 10754019200018 · Model: 11-4120 · CRH Medical Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    CRH O'Regan System
    Primary DI
    10754019200018
    Version / Model
    11-4120
    Catalog Number
    11-4120
    Company Name
    CRH Medical Corporation
    Labeler DUNS
    243137838
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2016-10-30
    Public Version
    3
    Public Version Date
    2020-10-16
    Public Version Status
    Update
    Public Device Record Key
    96238c0c-14dc-476d-be3e-5cd52fa178c3
    Distribution End Date
    2020-10-15

    Device Description

    A case containing 20 Individually sealed kits, each kit containing one ligator, a bag of 3 latex bands, a loading cone and a patient brochure.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FHN Ligator, Hemorrhoidal

    GMDN Terms

    Code Name
    35157 Haemorrhoid ligator

    Identifiers

    Type ID
    Primary 10754019200018
    Unit of Use 00754019200011