BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AED

    DI: 00848657006392 · Model: 8800F · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AED
    Primary DI
    00848657006392
    Version / Model
    8800F
    Company Name
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Labeler DUNS
    839138955
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-24
    Public Version
    4
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    4b0bce1c-e43f-4a10-abe3-6afd2bc6cac9

    Device Description

    AED Endoscope - Sinuscope 4.0mm x 45 degree, 175mm

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    EOB Nasopharyngoscope (flexible or rigid)

    GMDN Terms

    Code Name
    37180 Rigid optical sinoscope

    Identifiers

    Type ID
    Primary 00848657006392

    Premarket Submissions

    Submission Number Supplement Number
    K170285 000