BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cannula

    DI: 07290114060400 · Model: Standard · ALPHA OMEGA ENGINEERING CO. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cannula
    Primary DI
    07290114060400
    Version / Model
    Standard
    Catalog Number
    STR-021621-00
    Company Name
    ALPHA OMEGA ENGINEERING CO. LTD.
    Labeler DUNS
    531856466
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-03
    Public Version
    2
    Public Version Date
    2021-04-06
    Public Version Status
    Update
    Public Device Record Key
    bf56c1a2-1979-478d-8f06-e963b3722f0e
    Distribution End Date
    2021-04-05

    Device Description

    Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet

    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
    MR Unsafe
    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
    GZL Electrode, Depth

    GMDN Terms

    Code Name
    61964 Intracerebral cannula, implantable

    Identifiers

    Type ID
    Package 17290114060407
    Primary 07290114060400

    Customer Contacts

    Phone
    8779196288
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K120098 000