BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening

    · Expires 2025
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TEAL HEALTH, INC.
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1012 Torney Ave
    City
    San Francisco
    State
    CA
    ZIP
    94129
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240045

    Owner / Operator

    Firm Name
    Teal Health, Inc.
    Operator Number
    10093528
    Address
    1012 Torney Ave
    City
    San Francisco
    State
    CA
    Postal Code
    94129
    Country
    US
    Correspondent
    Trena Depel

    Products

    Device Name Product Code
    Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay SEP

    Proprietary Names

    Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility