BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CAP

    DI: 04953170054389 · Model: MH-365 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    CAP
    Primary DI
    04953170054389
    Version / Model
    MH-365
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    11
    Public Version Date
    2023-11-20
    Public Version Status
    Update
    Public Device Record Key
    91f7e9b4-b7fa-4adc-aefa-e922b8263e99
    Distribution End Date
    2022-08-19

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

    Product Codes

    Code Name
    GCJ Laparoscope, general & plastic surgery

    GMDN Terms

    Code Name
    61792 Endoscopic procedure air/water valve, reusable

    Identifiers

    Type ID
    Primary 04953170054389
    Unit of Use 84953170054385

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K944201 000