BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    SINGLE USE ASPIRATION NEEDLE

    DI: 04953170169977 · Model: NA-200H-8022 · 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
    Primary DI
    04953170169977
    Version / Model
    NA-200H-8022
    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
    4
    Public Version Date
    2022-06-24
    Public Version Status
    Update
    Public Device Record Key
    02d2cfc8-10a9-4032-852d-8750b097e967
    Distribution End Date
    2022-06-23

    Device Description

    SINGLE USE ASPIRATION NEEDLE

    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
    Yes
    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
    No

    Product Codes

    Code Name
    FCG Biopsy needle

    GMDN Terms

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

    Identifiers

    Type ID
    Package 14953170169974
    Primary 04953170169977

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K023272 000