BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    tezo-A™ titanium cage family

    DI: 04052536077779 · Model: CS 3434-10 · Ulrich GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    tezo-A™ titanium cage family
    Primary DI
    04052536077779
    Version / Model
    CS 3434-10
    Catalog Number
    CS 3434-10
    Company Name
    Ulrich GmbH & Co. KG
    Labeler DUNS
    315494757
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-30
    Public Version
    4
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    60f910fd-f8f5-4fd9-af0e-67d007af8a64

    Device Description

    tezo-A, height 10 mm, length x width 31 x 25 mm, angle 12°

    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 Conditional
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MAX Intervertebral fusion device with bone graft, lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 04052536077779

    Customer Contacts

    Phone
    +4907319654152
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K122957 000