BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ponto

    DI: 05712149027262 · Model: 254434 · Oticon Medical AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ponto
    Primary DI
    05712149027262
    Version / Model
    254434
    Catalog Number
    254434
    Company Name
    Oticon Medical AB
    Labeler DUNS
    554563994
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-21
    Public Version
    2
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    18a0a734-f6b7-4a23-863b-fab4ad12e37f

    Device Description

    SALES PACK, GENIE MEDICAL BAHS 2023.1 USB

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXB Hearing Aid, Bone Conduction

    GMDN Terms

    Code Name
    60211 Audiometric/hearing device software

    Identifiers

    Type ID
    Primary 05712149027262