BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CONDUIT ATP 6mm Spreader 24°

    DI: 09421028118460 · Model: 287363246 · ENZTEC LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CONDUIT ATP 6mm Spreader 24°
    Primary DI
    09421028118460
    Version / Model
    287363246
    Catalog Number
    287363246
    Company Name
    ENZTEC LIMITED
    Labeler DUNS
    592616445
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-04
    Public Version
    1
    Public Version Date
    2023-12-12
    Public Version Status
    New
    Public Device Record Key
    05b6837c-11a6-49b7-b2f0-ae8431b1a8f4

    Device Description

    Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    12696 Orthopaedic implant inserter/extractor, reusable

    Identifiers

    Type ID
    Primary 09421028118460