BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rigicon HL Dilator 10 – 12 mm

    DI: 00850015358449 · Model: RSUD-1012 · Rigicon, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rigicon HL Dilator 10 – 12 mm
    Primary DI
    00850015358449
    Version / Model
    RSUD-1012
    Catalog Number
    RSUD-1012
    Company Name
    Rigicon, Inc.
    Labeler DUNS
    045247683
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-02
    Public Version
    1
    Public Version Date
    2024-02-12
    Public Version Status
    New
    Public Device Record Key
    3fd1decc-d712-4e3c-be89-8efb84b10993

    Device Description

    Rigicon HL Dilator 10 – 12 mm Disposable

    Device Characteristics

    Single Use
    Yes
    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
    KOA Surgical Instruments, G-U, Manual (And Accessories)

    GMDN Terms

    Code Name
    60798 Penile prosthesis implantation instrument

    Identifiers

    Type ID
    Primary 00850015358449