BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPHTACATH® 2 mm Bilateral Kit

    DI: 13700773735102 · Model: S1.4122 · FCI S A S FCI 20 22
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPHTACATH® 2 mm Bilateral Kit
    Primary DI
    13700773735102
    Version / Model
    S1.4122
    Company Name
    FCI S A S FCI 20 22
    Labeler DUNS
    763408366
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-28
    Public Version
    1
    Public Version Date
    2024-01-05
    Public Version Status
    New
    Public Device Record Key
    9612884e-735a-4f44-872f-ea7e7dfa659c

    Device Description

    A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OKS Lacrimal Stents And Intubation Sets

    GMDN Terms

    Code Name
    45150 Ophthalmic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 13700773735102
    Previous 13760087123828