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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orbital sphere implant

    DI: 03760087122497 · Model: ENUCLEATION EVISCERATION IMPLANT Ø 18 MM · 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
    Orbital sphere implant
    Primary DI
    03760087122497
    Version / Model
    ENUCLEATION EVISCERATION IMPLANT Ø 18 MM
    Catalog Number
    S6.1018U
    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
    2020-02-25
    Public Version
    1
    Public Version Date
    2020-03-04
    Public Version Status
    New
    Public Device Record Key
    dd58b7be-8ba0-4902-85ea-7621e62076f1

    Device Description

    An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.

    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
    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
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    HPZ Implant, Eye Sphere

    GMDN Terms

    Code Name
    46902 Orbital sphere implant

    Identifiers

    Type ID
    Primary 03760087122497

    Customer Contacts

    Phone
    800-932-4202
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Outer Diameter 18 Millimeter