BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Single Use Aspiration Needle NA-U401SX

    DI: 04953170409998 · Model: NA-U401SX-4022 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Single Use Aspiration Needle NA-U401SX
    Primary DI
    04953170409998
    Version / Model
    NA-U401SX-4022
    Catalog Number
    R5000693
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-03
    Public Version
    1
    Public Version Date
    2024-07-11
    Public Version Status
    New
    Public Device Record Key
    4f41aa1d-67d9-4838-860a-98fc71ac4a8d

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    FCG Biopsy Needle

    GMDN Terms

    Code Name
    38825 General-purpose endoscopic needle, single-use

    Identifiers

    Type ID
    Package 14953170409995
    Primary 04953170409998

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K160098 000