BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EVIS EXERA lll COLONOVIDEOSCOPE

    DI: 04953170305252 · Model: OLYMPUS PCF-PH190I · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EVIS EXERA lll COLONOVIDEOSCOPE
    Primary DI
    04953170305252
    Version / Model
    OLYMPUS PCF-PH190I
    Catalog Number
    N3802840
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    6
    Public Version Date
    2023-12-27
    Public Version Status
    Update
    Public Device Record Key
    da707df5-01dd-4810-92b6-a2c1cf4ddfce

    Device Description

    "PCF-PH190I ULTRA SLIM EE III HD COLONOSC"

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "High-level Disinfectant"]

    Product Codes

    Code Name
    FDF Colonoscope and accessories, flexible/rigid
    FDS Gastroscope And Accessories, Flexible/Rigid
    NWB Endoscope, Accessories, Narrow Band Spectrum

    GMDN Terms

    Code Name
    36117 Flexible video colonoscope, reusable

    Identifiers

    Type ID
    Primary 04953170305252

    Customer Contacts

    Phone
    +1(800)401-1086
    Email
    [email protected]