BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm

    DI: 00850033207460 · Model: RSSL-1014 · Rigicon, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm
    Primary DI
    00850033207460
    Version / Model
    RSSL-1014
    Catalog Number
    RSSL-1014
    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
    02a061cc-3805-406a-9320-8ce3fa8a8db8

    Device Description

    Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    KOA Surgical Instruments, G-U, Manual (And Accessories)

    GMDN Terms

    Code Name
    46486 Gastro-urological director
    60171 Corpus cavernosum dilator, reusable

    Identifiers

    Type ID
    Primary 00850033207460