BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BALLOON APPLICATOR

    DI: 04953170065262 · Model: MD-688 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BALLOON APPLICATOR
    Primary DI
    04953170065262
    Version / Model
    MD-688
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    7
    Public Version Date
    2022-08-15
    Public Version Status
    Update
    Public Device Record Key
    7c9bd3a4-5005-4e82-a565-0ff33ce6b7f3
    Distribution End Date
    2022-08-12

    Device Description

    "MD-688 Balloon applicator for JF-UM20"

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

    Product Codes

    Code Name
    ITX Transducer, ultrasonic, diagnostic

    GMDN Terms

    Code Name
    62379 Surgical instrument assist arm system, manually-adjusted

    Identifiers

    Type ID
    Primary 04953170065262

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K900880 000