BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    audifon

    DI: EADF0221978542338117201 · Model: faro R · audifon GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    audifon
    Primary DI
    EADF0221978542338117201
    Version / Model
    faro R
    Catalog Number
    022197-8542-3381-1720
    Company Name
    audifon GmbH & Co. KG
    Labeler DUNS
    344064407
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-18
    Public Version
    3
    Public Version Date
    2020-10-06
    Public Version Status
    Update
    Public Device Record Key
    a6f111b4-6e6e-4996-9d7a-875e59a83715

    Device Description

    RITE

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OSM Hearing Aid, Air Conduction With Wireless Technology

    GMDN Terms

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

    Identifiers

    Type ID
    Primary EADF0221978542338117201