BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JAZZ System

    DI: 03607505502991 · Model: Tensioner Gen. II - 120° Stem · IMPLANET
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JAZZ System
    Primary DI
    03607505502991
    Version / Model
    Tensioner Gen. II - 120° Stem
    Catalog Number
    550299
    Company Name
    IMPLANET
    Labeler DUNS
    291993439
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    5
    Public Version Date
    2019-09-27
    Public Version Status
    Update
    Public Device Record Key
    84be773e-24ab-4086-83cd-8412c9c86c06

    Device Description

    Tensioner Gen. II - 120° Stem

    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
    OWI Bone Fixation Cerclage, Sublaminar

    GMDN Terms

    Code Name
    44801 Internal spinal fixation system cable tensioner

    Identifiers

    Type ID
    Primary 03607505502991

    Premarket Submissions

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

    Device Sizes

    Type Value Unit Text
    Angle 120 degree