BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tarsa-Link Wedge Fixation System

    DI: 00190837015503 · Model: 27-1613-710 · Life Spine, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tarsa-Link Wedge Fixation System
    Primary DI
    00190837015503
    Version / Model
    27-1613-710
    Company Name
    Life Spine, Inc.
    Labeler DUNS
    183641617
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-12
    Public Version
    3
    Public Version Date
    2021-06-08
    Public Version Status
    Update
    Public Device Record Key
    a415889c-ebf9-47f8-907e-c1a6d82bcc68

    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
    Yes
    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
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    61330 Polymeric osteotomy fusion cage, non-customized

    Identifiers

    Type ID
    Primary 00190837015503