BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    A&M

    DI: 04056839013243 · Model: S_ITE XTM IF A4 N-TAN R BG · Ws Audiology Usa, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    A&M
    Primary DI
    04056839013243
    Version / Model
    S_ITE XTM IF A4 N-TAN R BG
    Catalog Number
    10943612
    Company Name
    Ws Audiology Usa, Inc.
    Labeler DUNS
    157412271
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-08
    Public Version
    4
    Public Version Date
    2023-02-08
    Public Version Status
    Update
    Public Device Record Key
    5612f4dd-7311-4cc6-a17d-b1695b5c63e4

    Device Description

    A&M S_ITE XTM IF A4 N-TAN R BG Hearing Aid

    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
    ESD Hearing Aid, Air Conduction

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 04056839013243

    Customer Contacts

    Phone
    17325626600
    Email
    [email protected]