BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prosidio

    DI: 00850042909287 · Model: P49N70 · Prosidio LLC
    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
    Prosidio
    Primary DI
    00850042909287
    Version / Model
    P49N70
    Catalog Number
    P49N70
    Company Name
    Prosidio LLC
    Labeler DUNS
    035702151
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-05
    Public Version
    1
    Public Version Date
    2025-12-15
    Public Version Status
    New
    Public Device Record Key
    0c6bd98b-e677-4cff-9be0-f16c71855e14

    Device Description

    70° angle, 4mm diameter, 90mm length otoscope

    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
    Yes
    Sterilization Methods
    High-level Disinfectant

    Product Codes

    Code Name
    ERA Otoscope

    GMDN Terms

    Code Name
    12849 Otoscope, direct

    Identifiers

    Type ID
    Primary 00850042909287