BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cortium Universal OCT Spinal Fixation System

    DI: 00814386028295 · Model: UU072-12-0145 · Ulrich Medical Usa, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cortium Universal OCT Spinal Fixation System
    Primary DI
    00814386028295
    Version / Model
    UU072-12-0145
    Company Name
    Ulrich Medical Usa, Inc.
    Labeler DUNS
    624083866
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-19
    Public Version
    2
    Public Version Date
    2024-06-20
    Public Version Status
    Update
    Public Device Record Key
    442e16d7-d8c0-4748-a0b3-e5b096051bd4

    Device Description

    Tap, Ø 4.5mm, thoracic, AO coupling, cannulated, single use

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NKG Posterior Cervical Screw System

    GMDN Terms

    Code Name
    56708 Bone tap, single-use

    Identifiers

    Type ID
    Primary 00814386028295

    Customer Contacts

    Phone
    636-519-0268
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K230614 000