BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    audioprint INR-1

    DI: EPRCA1000288 · Model: 1000 g bottle ; Pink Translucent · pro3dure medical GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    audioprint INR-1
    Primary DI
    EPRCA1000288
    Version / Model
    1000 g bottle ; Pink Translucent
    Catalog Number
    A1000288
    Company Name
    pro3dure medical GmbH
    Labeler DUNS
    312947842
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-06
    Public Version
    1
    Public Version Date
    2022-12-14
    Public Version Status
    New
    Public Device Record Key
    623935af-6dcf-4594-8bb0-42063f9f6de9

    Device Description

    audioprint INR-1 Generative resin for production of earpieces

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    41228 Earmould, custom-made

    Identifiers

    Type ID
    Primary EPRCA1000288