BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Signia

    DI: 04063006012824 · Model: Pure 312 1X · Ws Audiology Usa, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Signia
    Primary DI
    04063006012824
    Version / Model
    Pure 312 1X
    Catalog Number
    10981763
    Company Name
    Ws Audiology Usa, Inc.
    Labeler DUNS
    157412271
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-06
    Public Version
    1
    Public Version Date
    2023-09-14
    Public Version Status
    New
    Public Device Record Key
    f2ff9fa2-70a9-49d8-8761-08455902120e

    Device Description

    Pure 312 1X Silver

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KLW Masker, Tinnitus

    GMDN Terms

    Code Name
    47169 Air-conduction hearing aid, receiver-in-canal

    Identifiers

    Type ID
    Primary 04063006012824

    Customer Contacts

    Phone
    17325626600
    Email
    [email protected]