BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX

    DI: 04961333083015 · Model: OF-D1 · HOYA CORPORATION
    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
    PENTAX
    Primary DI
    04961333083015
    Version / Model
    OF-D1
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-31
    Public Version
    1
    Public Version Date
    2023-08-08
    Public Version Status
    New
    Public Device Record Key
    c184f73a-d080-4f25-9113-cbcecb9a7aa3

    Device Description

    Eyepiece Cap OF-D1

    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
    Yes
    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
    Yes
    Sterilization Methods
    High-level Disinfectant, Ethylene Oxide

    Product Codes

    Code Name
    EOQ Bronchoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    64377 Endoscope viewfinder cap

    Identifiers

    Type ID
    Primary 04961333083015

    Premarket Submissions

    Submission Number Supplement Number
    K951199 000