BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lacrimal dilator, reusable

    DI: 03760087126075 · Model: DOUBLE DILATOR · 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
    Lacrimal dilator, reusable
    Primary DI
    03760087126075
    Version / Model
    DOUBLE DILATOR
    Catalog Number
    A8.4050
    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
    2020-02-26
    Public Version
    1
    Public Version Date
    2020-03-05
    Public Version Status
    New
    Public Device Record Key
    72c9b2de-583a-4a9b-8fc5-674a0c084fa2

    Device Description

    A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HNW Dilator, Lachrymal

    GMDN Terms

    Code Name
    35010 Lacrimal dilator, reusable

    Identifiers

    Type ID
    Primary 03760087126075

    Customer Contacts

    Phone
    800-932-4202
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 119 Millimeter