BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    TearCare(TM) (2.2) System Kit

    DI: 00858027006273 · Model: FG 06041 · Sight Sciences, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TearCare(TM) (2.2) System Kit
    Primary DI
    00858027006273
    Version / Model
    FG 06041
    Catalog Number
    5-100
    Company Name
    Sight Sciences, Inc.
    Labeler DUNS
    962750381
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-27
    Public Version
    3
    Public Version Date
    2023-08-22
    Public Version Status
    Update
    Public Device Record Key
    65e9fe0a-f327-4e88-b0d9-6a43fd74c8b0
    Distribution End Date
    2022-03-24

    Device Description

    TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IRT Pad, Heating, Powered

    GMDN Terms

    Code Name
    62518 Eyelid heat therapy system control unit

    Identifiers

    Type ID
    Primary 00858027006273