BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JAZZ System

    DI: 03607503501583 · Model: JAZZ – Open Braid V2 · IMPLANET
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JAZZ System
    Primary DI
    03607503501583
    Version / Model
    JAZZ – Open Braid V2
    Catalog Number
    350158
    Company Name
    IMPLANET
    Labeler DUNS
    291993439
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-23
    Public Version
    6
    Public Version Date
    2019-09-26
    Public Version Status
    Update
    Public Device Record Key
    b8d09702-8dc2-444d-8503-a6a29e75d474

    Device Description

    JAZZ – Open Braid V2

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWI Bone Fixation Cerclage, Sublaminar

    GMDN Terms

    Code Name
    37272 Trans-facet-screw internal spinal fixation system, sterile

    Identifiers

    Type ID
    Primary 03607503501583

    Premarket Submissions

    Submission Number Supplement Number
    K151740 000
    K160226 000
    K170730 000
    K171881 000
    K182771 000
    K191217 000