BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MENIX DUO

    DI: 03760304680526 · Model: Meniscal suture system, 2 anchors · S.B.M
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MENIX DUO
    Primary DI
    03760304680526
    Version / Model
    Meniscal suture system, 2 anchors
    Catalog Number
    MEN0201901
    Company Name
    S.B.M
    Labeler DUNS
    772462123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-22
    Public Version
    1
    Public Version Date
    2023-08-30
    Public Version Status
    New
    Public Device Record Key
    34f262dd-1c13-41c8-b880-918e29ae09b0

    Device Description

    MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture.

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

    GMDN Terms

    Code Name
    66530 Meniscus suture anchor

    Identifiers

    Type ID
    Primary 03760304680526

    Premarket Submissions

    Submission Number Supplement Number
    K223122 000