BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TearCare System - TearCare SmartHub Kit

    DI: 00858027006457 · Model: FG 07392 · Sight Sciences, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TearCare System - TearCare SmartHub Kit
    Primary DI
    00858027006457
    Version / Model
    FG 07392
    Catalog Number
    5-116
    Company Name
    Sight Sciences, Inc.
    Labeler DUNS
    962750381
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-03
    Public Version
    2
    Public Version Date
    2023-08-22
    Public Version Status
    Update
    Public Device Record Key
    1a811121-a176-44b8-b119-458e532da73a

    Device Description

    TearCare System SmartHub Kit including SmartHub, charging nest, and charging 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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    ORZ Eyelid Thermal Pulsation System

    GMDN Terms

    Code Name
    62518 Eyelid heat therapy system control unit

    Identifiers

    Type ID
    Primary 00858027006457

    Premarket Submissions

    Submission Number Supplement Number
    K213045 000