BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Olympus Pacific

    DI: 00821925032927 · Model: 70140399 · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Olympus Pacific
    Primary DI
    00821925032927
    Version / Model
    70140399
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-03
    Public Version
    6
    Public Version Date
    2023-09-29
    Public Version Status
    Update
    Public Device Record Key
    e2aa0684-050d-49fe-9ece-ec36b3d1dfd0
    Distribution End Date
    2017-12-07

    Device Description

    ARMSTRONG V TYPE VENT TUBE STRAIGHT, BLUE 1.14 MM ID 4.5 MM LENGTH FLUOROPLACTIC PACIFIC

    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
    No

    Product Codes

    Code Name
    ETD TUBE, TYMPANOSTOMY

    GMDN Terms

    Code Name
    33794 Tympanostomy tube

    Identifiers

    Type ID
    Package 00821925020238
    Primary 00821925032927

    Premarket Submissions

    Submission Number Supplement Number
    K000801 000