BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX

    DI: 04961333228577 · Model: FC-38LV · HOYA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PENTAX
    Primary DI
    04961333228577
    Version / Model
    FC-38LV
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-07
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    9154e313-6c08-4cc6-89a7-0451c1aa8416

    Device Description

    Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.

    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
    No
    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
    FDF Colonoscope and accessories, flexible/rigid

    GMDN Terms

    Code Name
    34966 Flexible fibreoptic colonoscope

    Identifiers

    Type ID
    Primary 04961333228577