BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OES HYSTEROFIBERSCOPE

    DI: 04953170411571 · Model: OLYMPUS HYF TYPE XP · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OES HYSTEROFIBERSCOPE
    Primary DI
    04953170411571
    Version / Model
    OLYMPUS HYF TYPE XP
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-29
    Public Version
    2
    Public Version Date
    2021-12-15
    Public Version Status
    Update
    Public Device Record Key
    64b1df34-bcd0-418c-85c2-3034f7a736ec

    Device Description

    OES HYSTEROFIBERSCOPE

    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
    ["High-level Disinfectant", "Ethylene Oxide"]

    Product Codes

    Code Name
    HIH HYSTEROSCOPE (AND ACCESSORIES)

    GMDN Terms

    Code Name
    37152 Flexible fibreoptic hysteroscope

    Identifiers

    Type ID
    Primary 04953170411571

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K891451 000