BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Python Plate LEFT

    DI: 00853114006037 · Model: SD11 · Treace Medical Concepts, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Python Plate LEFT
    Primary DI
    00853114006037
    Version / Model
    SD11
    Company Name
    Treace Medical Concepts, Inc.
    Labeler DUNS
    054808082
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-27
    Public Version
    4
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    078ee079-8576-4f34-bc9f-7f95147ee78f

    Device Description

    Anatomic Tension Side Plate

    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
    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
    HWC Screw, Fixation, Bone
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    61690 Internal orthopaedic fixation system, cerclage wire/cable, sterile

    Identifiers

    Type ID
    Primary 00853114006037