BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    TearCare iLid Pair

    DI: 00858027006228 · Model: FG 05118 · Sight Sciences, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TearCare iLid Pair
    Primary DI
    00858027006228
    Version / Model
    FG 05118
    Company Name
    Sight Sciences, Inc.
    Labeler DUNS
    962750381
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-01
    Public Version
    5
    Public Version Date
    2023-08-22
    Public Version Status
    Update
    Public Device Record Key
    8bc37ff3-13ce-4ec9-9331-30faa9c731d3
    Distribution End Date
    2019-08-01

    Device Description

    Eyelid heat therapy system applicator

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IRT Pad, Heating, Powered

    GMDN Terms

    Code Name
    62516 Eyelid heat therapy system applicator

    Identifiers

    Type ID
    Primary 00858027006228
    Package 10858027006225