BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eyelid weight, implantable

    DI: 03760087120806 · Model: PTOSE-UP 2 mm WIDTH J.M. RUBAN M.D. · 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
    Eyelid weight, implantable
    Primary DI
    03760087120806
    Version / Model
    PTOSE-UP 2 mm WIDTH J.M. RUBAN M.D.
    Catalog Number
    S3.3021u
    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
    001ec056-2e5e-4f1e-b0c7-69f0a7efb8f7

    Device Description

    An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].

    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
    Yes
    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
    Ethylene Oxide

    Product Codes

    Code Name
    HJZ Crutch, Ptosis

    GMDN Terms

    Code Name
    18074 Eyelid weight, implantable

    Identifiers

    Type ID
    Primary 03760087120806

    Customer Contacts

    Phone
    800-932-4202
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 150 Millimeter