BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPHERE INTRODUCER

    DI: 13760087126386 · Model: S6.3050 · FCI S A S FCI 20 22
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPHERE INTRODUCER
    Primary DI
    13760087126386
    Version / Model
    S6.3050
    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
    2021-05-30
    Public Version
    1
    Public Version Date
    2021-06-07
    Public Version Status
    New
    Public Device Record Key
    a01c7e41-9f45-4373-86d9-5c07601508d0

    Device Description

    A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.

    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
    No
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HNP Introducer, Sphere

    GMDN Terms

    Code Name
    32766 Orbital sphere implant introducer

    Identifiers

    Type ID
    Primary 13760087126386