BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tritium Sternal Cable Plate System

    DI: 00846468080495 · Model: 86-PLTCUTTER-3 · Pioneer Surgical Technology, Inc.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tritium Sternal Cable Plate System
    Primary DI
    00846468080495
    Version / Model
    86-PLTCUTTER-3
    Catalog Number
    86-PLTCUTTER-3
    Company Name
    Pioneer Surgical Technology, Inc.
    Labeler DUNS
    793384496
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-27
    Public Version
    3
    Public Version Date
    2021-10-14
    Public Version Status
    Update
    Public Device Record Key
    072fbb30-9548-4633-a33c-94c5e24d26ab

    Device Description

    Plate Cutter

    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
    No
    PM Exempt
    Yes
    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
    HWC Screw, Fixation, Bone
    HRS Plate, Fixation, Bone
    JDQ Cerclage, Fixation
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    34017 Sternal fixation device

    Identifiers

    Type ID
    Primary 00846468080495