BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    America Hears®

    DI: 00812944023904 · Model: HS 32 · HEARING LAB TECHNOLOGY, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    America Hears®
    Primary DI
    00812944023904
    Version / Model
    HS 32
    Catalog Number
    GWP-AHICUSHS
    Company Name
    HEARING LAB TECHNOLOGY, LLC
    Labeler DUNS
    827693503
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-21
    Public Version
    2
    Public Version Date
    2020-10-06
    Public Version Status
    Update
    Public Device Record Key
    6d42838a-b3b9-41e1-921b-863c9020b99d

    Device Description

    Custom Half Shell PLD 32

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    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
    ESD Hearing aid, air conduction

    GMDN Terms

    Code Name
    34672 Air-conduction hearing aid, in-the-ear

    Identifiers

    Type ID
    Primary 00812944023904

    Customer Contacts

    Phone
    +1(800)492-4515
    Email
    [email protected]