BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ENDOSKELETON® TT

    DI: 00191375051237 · Model: 160-020-001 · TITAN SPINE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENDOSKELETON® TT
    Primary DI
    00191375051237
    Version / Model
    160-020-001
    Catalog Number
    160-020-001
    Company Name
    TITAN SPINE, LLC
    Labeler DUNS
    623316978
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-01
    Public Version
    8
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    5e266104-eede-435b-9f21-2c8a75b0274c
    Distribution End Date
    2020-09-18

    Device Description

    Perforated, Tray, Base

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    MAX Intervertebral fusion device with bone graft, lumbar

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00191375051237

    Customer Contacts

    Phone
    +1(262)242-7801
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K083714 000