BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HYSTERO CATH

    DI: 00812261016689 · Model: HYSTERO CATH Hysterosalpingography Catheter Closed Tip · ALLWIN MEDICAL DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HYSTERO CATH
    Primary DI
    00812261016689
    Version / Model
    HYSTERO CATH Hysterosalpingography Catheter Closed Tip
    Catalog Number
    HC-HSG7
    Company Name
    ALLWIN MEDICAL DEVICES, INC.
    Labeler DUNS
    796354509
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-28
    Public Version
    1
    Public Version Date
    2023-08-07
    Public Version Status
    New
    Public Device Record Key
    4f8fdb7f-9f83-4395-b2e4-a93f949b36ef

    Device Description

    HYSTERO CATH Hysterosalpingography Catheter Closed Tip

    Device Characteristics

    Single Use
    Yes
    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
    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
    LKF Cannula, Manipulator/Injector, Uterine

    GMDN Terms

    Code Name
    18746 Intrauterine imaging medium catheter

    Identifiers

    Type ID
    Primary 00812261016689
    Package 10812261016686

    Customer Contacts

    Phone
    714-572-1709
    Email
    [email protected]