BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Scleral buckling device, non-bioabsorbable

    DI: 03760087121544 · Model: FIXATION SLEEVE FOR S5.1015U TYPE 71 · FCI S A S FCI 20 22
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    Scleral buckling device, non-bioabsorbable
    Primary DI
    03760087121544
    Version / Model
    FIXATION SLEEVE FOR S5.1015U TYPE 71
    Catalog Number
    S5.3515U
    Company Name
    FCI S A S FCI 20 22
    Labeler DUNS
    763408366
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2020-03-06
    Public Version
    2
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    11ad3bb9-3859-4cdd-b8b1-0e6f07c8ce42

    Device Description

    A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    HQX Implant, Orbital, Extra-Ocular

    GMDN Terms

    Code Name
    42545 Scleral buckling device, non-bioabsorbable

    Identifiers

    Type ID
    Unit of Use 53760087121549
    Primary 03760087121544

    Customer Contacts

    Phone
    800-932-4202
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 30 Millimeter
    Outer Diameter 2.16 Millimeter
    Lumen/Inner Diameter 1.02 Millimeter